Devices

Decathlon

Model / Serial
All lot codes
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide distribution - Nationwide, Government. Foreign: Canada, France.
Product Description
32CM ALTA EXCHANGE || Model: AL27SH32 XP || ALTA EXCHANGE KIT || 15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Latex free
Manufacturer
Spire Biomedical, Inc.
23 Events

Manufacturer

Spire Biomedical, Inc.

Manufacturer Address
Spire Biomedical, Inc., One Patriots Park, Bedford MA 01730-2343
Manufacturer Parent Company (2017)
Spire Corporation
Source
USFDA

5 devices with a similar name

Learn more about the data here

Decathlon Funnel Kit

Model / Serial
All lot codes
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide distribution - Nationwide, Government. Foreign: Canada, France.
Product Description
40CM DECATHLON FUNNEL TIP STD KIT || Model: DF35SH40 || DECATHLON FUNNEL TIP || 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated funnel tips, cuff and side holes for chronic hemodialysis and || apheresis. Kit contains catheter with stylet, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch guidewire, 12Fr dilator, || 14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free.
Manufacturer
Spire Biomedical, Inc.

Decathlon Funnel Tip

Model / Serial
All lot codes
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide distribution - Nationwide, Government. Foreign: Canada, France.
Product Description
28CM DECATHLON FUNNEL TIP STD KIT || Model: DF23SH28 || DECATHLON FUNNEL TIP || 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated funnel tips, cuff and side holes for chronic hemodialysis and || apheresis. Kit contains catheter with stylet, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch guidewire, 12Fr dilator, || 14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free.
Manufacturer
Spire Biomedical, Inc.

Decathlon FunnelTip

Model / Serial
All lot codes
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide distribution - Nationwide, Government. Foreign: Canada, France.
Product Description
36CM DECATHLON FUNNEL TIP STD KIT || Model: DF31SH36 || DECATHLON FUNNEL TIP || 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated funnel tips, cuff and side holes for chronic hemodialysis and || apheresis. Kit contains catheter with stylet, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch guidewire, 12Fr dilator, || 14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free
Manufacturer
Spire Biomedical, Inc.

Decathlon Gold

Model / Serial
All lot codes
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide distribution - Nationwide, Government. Foreign: Canada, France.
Product Description
32CM DECATHLON GOLD STD KIT || Models: DEC27SH32 and DEC27SH32-K || DECATHLON GOLD || 15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated tips, cuff and side holes for chronic || hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch guidewire, 12Fr || dilator, 14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free.
Manufacturer
Spire Biomedical, Inc.

Decathlon Gold Funnel

Model / Serial
All lot codes
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide distribution - Nationwide, Government. Foreign: Canada, France.
Product Description
28CM DECATHLON GOLD FUNNEL TIP STD KIT || Models: DFC23SH28 and DFC23SH28-K || DECATHLON GOLD FUNNEL TIP || 15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated funnel tips, cuff and side holes for chronic || hemodialysis and apheresis. Kit contains catheter with stylet, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch || guidewire, 12Fr dilator, 14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free.
Manufacturer
Spire Biomedical, Inc.

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

Stories in your inbox

Do you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. We want to hear from you.

Tell us your story!

Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

Download the data

The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

Download all (zipped)