Boston Scientific

Model numbers 8031, 8038, 8048, 8060, 8075. 510(k) numbers K983171, K992777, K000277, K021232, K003782. Product Code DXQ. Product UPN numbers: Domestic: Constellation 31 mm/2mm: M004 US8031 0, M004 US8031 L0, M004 US8031 M0. 38mm/3mm: M004US8038 0, 4004 US8038 L0, M004 US8038P0. 48MM/4MM M004 US8048 0, M004 US8048B0, M004 US8048P0. 60mm/5mm: M004 US8060 0, M004 US8060B0, M004 US8060P0. 75mm/7mm: M004 US0875 0, M004 US0875B0, M004 US8075P0.   Outside of US product: Constellation 31 mm/2mm: M004 EPT8031 0, M004 EPT8031 L0, M004 EPT8031 M0. 38mm/3mm: M004EPT8038 0, 4004 EPT8038 L0, M004 EPT8038P0. 48MM/4MM M004 EPT8048 0, M004 EPT8048B0, M004 EPT8048P0. 60mm/5mm: M004 EPT8060 0, M004 EPT8060B0, M004 EPT8060P0. 75mm/7mm: M004 EPT0875 0, M004 EPT0875B0, M004 EPT8075P0.

Cardiovascular Devices

2

No

This product was distributed to 521 accounts worldwide.

Constellation Advanced Mapping Catheter, Model numbers 8031, 8038, 8048, 8060, 8075

Catalog #, Lot Numbers:  333603--Lot #s 0060529076,0060542787, 0060551433, 0060552115, 0060553837, 0060562411, 0060702019, 0060702049. 333604--0060553838, 0060708443, 0060713806. 333606--0060472888, 0060516047, 0060583876, 0060710305, 0060710306, 0060751880. 333608--0060569225, 0060703806, 0060729030, 3360734585. 333609--0060703808. 333610--0060738852. 333612--0060542791, 0060549251, 0060553963, 0060702064, 0060708037. 333613--0060549252, 0060553909, 0060702069, 0060702071, 0060702074. 333614--0060521374, 0060551766, 0060702082. 610064--0060709374. 610100--0060702177, 0060761533. 610101--0060702179. 610102--0060710159. 610103--0060713850. 610104--0060734898, 0060741005. 610105--0060722688, 0060740847. 610106--0060702186. 610108--0060702192. 610109--0060713856. 610112--0060719604. 610113--0060723081. 610145--0060570243. 610146--0060560608. 610150--0060551068. 610151--0060707659, 0060710792. 610152--0060710794. 610153--0060551073, 0060568835. 610155--0060708367, 0060708367, 0060742089. 610177--0060558435, 0060707652, 0060709662, 0060746191, 0060766191. 610264--0060707534. 610407--0060732173. 610559--0060523821, 0060555811, 0060572434, 0060709663, 0060726953, 0060733425. 610570--0060726955. 610652--0060707368, 0060737064. 610654--006545559, 0060552179, 0060744541. 610811--0060473107, 0060473108, 0060560316, 0060738144. 610812--0060726992. 610813--0060757144. 610814--0060572400, 0060732297. 610815--0060538361, 0060542288, 0060757084. 610816--0060520549, 0060523748, 0060538364, 0060572403, 0060710820, 0060722731. 610817--0060544240, 0060545503, 0060569903, 0060571978. 610818--0060528048, 0060561924, 0060709739, 0060726994. 610819--0060545504, 0060709740, 0060727002. 610820--0060707651. 610830--0060712212, 0060742386. 610843--0060709735. 610894--0060544824, 0060545508, 0060557624, 0060707071, 0060715230, 0060728009, 0060752044, 0060752045. 610916--0060710874, 0060710875. 610923--0060497968, 0060545511, 0060754189, 0060516182, 0060545512, 0060569910. 610974--0060719256. 610976--0060517487, 0060551012, 0060564301, 0060571977, 0060709065, 0060719972. 610982--0060725523. 611109--0060523767, 0060545524, 0060551019, 0060555703, 0060706362, 0060707365, 0060709725, 0060716210. 611172--0060706038. 611840--0060519177, 0060540542, 0060545484, 0060552193, 0060564379, 0060707285, 0060711192, 0060722451. 612001--0060528366, 0060541715, 0060709669. 612122--0060752209. 612124--0060755565, 0060759158. 614006--0060545527, 0060545529, 0060548273, 0060555801, 0060564933, 0060569911, 0060572409, 0060706138, 0060706158, 0060706169, 0060706174, 0060709679, 0060749179. 614007--0060473083, 0060494998, 0060503536, 0060507452, 0060517491, 0060545530, 0060545531, 0060551054, 0060564304, 0060564934, 0060566303, 0060566304, 0060566305, 0060712277, 0060720315, 0060724332, 0060726782, 0060750181. 614008--0060545533, 0060548274, 0060554892, 0060555802, 0060564936, 0060568832, 0060569912, 0060572414, 0060576479, 0060576483, 0060576484, 0060712278, 0060712279, 0060712280, 0060737734. 614012--0060747064. 614037--0060547187, 0060735870. 614100--0060709646, 0060709647, 0060715276, 0060720258, 0060521185, 0060536288, 0060538205, 0060551057, 0060560474, 0060572417. 614101--0060709664, 0060709667, 0060715113. 614102--0060562423, 0060710927. 614104--0060580188, 0060707545. 614400--0060588319, 0060707536, 0060707537, 0060707538, 0060712281, 0060722450, 00607727033, 0060749069. 610107A--0060702191, 0060746124. 610154A--0060709726. 7B2807--0060709702, 0060709703, 0060709704, 0060709705, 0060709709, 0060709710, 0060709711, 0060709719, 0060749170. 7C2100--0060707500, 0060707501, 0060709659. 7C6311--0060482936, 0060489182, 0060496750, 0060505790, 0060506316, 0060523417, 006055541633, 0060543824, 0060543825, 0060543826, 0060548258, 0060555712, 0060557290, 0060561310, 0060578814, 0060710970, 0060720149, 0060726624. 7M3882--0060551059, 0060572130, 0060710976, 0060738147, 0060746766. 7M3883--0060707663, 0060725281.

Cardiovascular Devices

2

No

The firm distributed the product to 235 customers both US and International. The international customers are located in Germany, Canada, India, Japan, France, Venezuela, Ireland, and Chile.

Locking Tear-Away Sheath Introducer Product Line. || ACCUGUIDE SINGLE LUMEN 4FR PICC P460K 5/; || P560K PICC 5FR W/INTRO KIT; || MTI451845 4.5FR MINI T/A; || MTI551845 5.5FR MINI TA; || MTI651845 6.5FR MINI T/A; || P460OTW SNGL LUM PICC W/MTI; || P4552K DBL LUM PICC INTRO KIT; || P5552K DBL LUM PICC INTRO KIT; || P4552KOTW DBL LUM OTW PICC INTRO KIT LF; || LOCKING T/A INTRODUCERS 11FR; || INTRADYN TEAR-AWAY INTRODUCER 4F; || INTRADYN TEAR-AWAY INTRODUCER 5F; || INTRADYN TEAR-AWAY INTRODUCER 6F; || INTRADYN TEAR-AWAY INTRODUCER 7F; || INTRADYN TEAR-AWAY INTRODUCER 8F; || INTRADYN TEAR-AWAY INTRODUCER 9F; || INTRADYN TEAR-AWAY INTRODUCER 10F; || INTRADYN TEAR-AWAY INTRODUCER 11F; || INTRADYN TEAR-AWAY INTRODUCER 12F; || INTRADYN TEAR-AWAY INTRODUCER 15F; || INTRADYN TEAR-AWAY INTRODUCER 16F; || 23HI120 12F X 23CM HEMO INTRO; || 23HI130 13F X 23CM HEMO INTRO; || 30STA8 8FR X30CM T/A INTRO -NJ*; || 30STA9 9FR X 30CM SHEATH -NJ*; || 30STA10 10FR X 30CM T/A INTRO -NJ*; || 30STA12 12FR X 30CM T/A INTRO -NJ*; || 30STA16 16FR X 30CM SHEATH; || BOSTON SCI 16F X 9.54 STEP DIL/SHEATH; || 45STA9 45CM T/A INTRODUCER -NJ*; || LUTHER 6F - T/A ASSM CLIP; || 10HI14038 14F X 11CM HEMO W/WI; || BOSTON SCI 12FX 21.35 DIL/SHEATH; || 10HI12038 12F X 11CM HEMO W/WI; || 10HI13038 13F X 11CM HEMO W/WI; || BOSTON SCI 9F X 9.54 STEP DIL/SH; || BOSTON SCI 9F X 15.44 STEP DIL/SH; || BOSTON SCI 9F X 21.35 STEP DIL/SH; || BOSTON SCI 11F X 9.54 STEP DIL/SH; || BOSTON SCI 11F X 15.44 STEP DIL/SH; || BOSTON SCI 12F X 9.54 DIL/SHEATH; || BOSTON SCI 12F X 15.44 DIL/SHEATH; || BOSTON SCI 14F X 9.54 DIL/SHEATH; || BOSTON SCI 14F X 15.44 DIL/SHEATH; || BOSTON SCI 16F X15.44 DIL/SHEATH; || 30STA15 15FR LONG TA INTRODUCR; || 30STA11 11FR LONG TA INTRODUCR -NJ*; || CARDIAC PACEMAKER T/A SHEATH; || 14FR TA DILATOR/SHEATH-BULK; || 12FR INTRODUCER TEAR AWAY BNS; || 12FR TA DIL/SHEATH LC; || 8FR TA SHEATH; || 10FR TA SHEATH; || 16FR TA SHEATH; || 8/10FR LOCK T/A INTRO STEPPED; || 6FR T/A DILATOR/SHEATH; || 6FR LOCKING T/A INTRO ASSY; || 14FR X 143MM LOCKING T/A INTRODUCERS; || PTFE 4.5 FR BARD ACCESS INTRODUCERS; || PTFE 6.0 FR BARD ACCESS INTRODUCERS; || 7F LOCKING INTRO SYSTEM; || 8 (O/S) FR. LOCKING TEARAWAY INTRODUCER; || 9 FR (0/S) LOCKING INTRO SYSTEM; || 12F LOCKING INTRO SYSTEM; || 14FR LOCKING T/A INTRODUCER; || 10FR X 18 CM LOCKING T/A INTRODUCER; || 14FR X 12MM LOCKING T/A INTRODUCER; || 10.5FR X 18CM LOCKING T/A INTRODUCER; || 10FR X 23CM LOCKING T/A INTRODUCER; || 10FR LOCKING TEAR-AWAY INTRODUCERS; || INTRADYN TEAR-AWAY INTRODUCER 10.5F; || 30STA14 14FR X 30CM T/A INTRO -NJ*; || BOSTON SCIENTIFIC 15FR LOCKING TEARAWAY; || CELSA 5FR LOCKING T/A INTRODUCER; || CORDIS 4'' BLUNT TIP T/A SHEATH; || MEDTRONIC PS MED INTRO ASM 14F -NJ*; || MEDTRONIC PS MED INTRO ASM 15F.

934445 exp. 2/28/2007; 942510 exp. 1/31/2007; 938122 exp. 3/31/2007; 935225 exp. 2/28/2007; 933703 exp 1/21/2007; 931401 exp. 12/31/2006; 929657 exp. 12/31/2006; 929435 exp. 12/31/2006.

General Hospital and Personal Use Devices

2

Yes

278 units shipped to 31 consignees throughout the U.S. 12 units shipped to one foreign consignees located in the UK.

PASV Central Venous Catheter, 7F, Cat. # CVC702IK, Model # M0001CVC702IK. The 7Fr PASV Central Venous Catheter is a packaged configuration comprised of a silicone Central Venous Catheter with PASV Valve, Guidewire, Syringe, Needle, Tunneler, Scalpel, Sheath/Dilator, and caps. Firm on the label: Boston Scientific*** Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.

(1) Medical University of SC label: Lot 942414 (2) Covenant label: Lot 939982, 943645;  (3) St. Joseph label: Lot 940424;  (4) Spectrum label: Lot 940054 (5) Rush Foundation label: Lot 945456; 943043

Cardiovascular Devices

2

No

The kits were custom made and sold to consignees in IL, KY, MI, SC, and TX.

NAMIC Custom Angiographic Kit'' sold under the following labels: || (1) Medical University of South Carolina. Pouch Catalog # 60131481; || (2) Covenant Medical Center, Pouch Catalog #60131603; || (3) St. Joseph Hospital, Pouch Catalog #60101041; || (4) Spectrum Health, Pouch Catalog #61020031 || (5) Rush Foundation Hospital, Kit #65185472 ****** || Responsible firm on product labels: Boston Scientific/SCIMED *** Manufactured by: Boston Scientific Corporation / NAMIC Technology Center / Glens Falls, New York 12801. ****** || Each kit is customized to the needs of the particular hospital identified on the product labeling.

Lot Numbers: 7355316 7382682 7401867

Gastroenterology-Urology Devices

2

Yes

Nationwide VA Hopsitals Foreign: Canada, Africa, Japan, Israel, Japan, Nertherlands, Venezula

Banana Peel™ Sheaths BP/11/15 || Catalog Number: 20-607