Biliary Catheters

  • Model / Serial
    Model Numbers: Lot Numbers A4752: 1165670. A4754: 1156762. A4762: 1155852, 1165674. CB052308: 1164350. CB054008: 1164305. CB062313: 1164306.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of United Arab Emirates, Austria, Australia, Belgium, Canada, Germany, Ecuador, Estonia, Spain, France, United Kingdom, Hong Kong, Ireland, Israel, Italy, Republic of Korea, Libyan Arab Jamahiriya, Malaysia, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Serbia, Saudi Arabia, Taiwan, and South Africa.
  • Product Description
    Biliary Catheters (Models A47XX and CB0XXXXX): || Model Numbers & Description: || A4752, SYNTEL BILIARY 5F-23CM CATHETER; || A4754, SYNTEL BILIARY 5F-40CM CATHETER; || A4762, SYNTEL BILIARY 6F-23CM CATHETER; || CB052308, SYNTEL BILIARY 5F-23CM CATH; || CB054008, SYNTEL BILIARY 5F-40CM CATH; || CB062313, SYNTEL BILIARY 6F-23CM CATH. || Biliary Catheters are indicated for the removal of stones and ductal debris from the biliary system.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Applied Medical Resources Corp, 22872 Avenida Empresa # 3, Rancho Santa Margarita CA 92688-2650
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

3 devices with a similar name

Learn more about the data here

  • Model / Serial
    Model: Model Numbers: A4403, A4405, A4406, A4407, A4752, A4F00, A4F01, A4F02, A4F03, A4F04, A4F05, A4F06, A4F07, A4F08., Affected: 48 lots
  • Manufacturer
  • Model / Serial
    Syntel Vascular Catheters and Syntel Biliary Catheters (embolectomy catheter)Syntel Vascular CathetersModel Numbers: A4403, A4405 to A4407 (inc), A4F00 to A4F08 (inc.)Lot Numbers: Multiple lots affectedARTG Number: 116754Syntel Biliary CathetersModel numbers: A4752Lot numbers: 1165670ARTG Number: 116815
  • Product Classification
  • Manufacturer