510(k) K963981 ยท FPA Set, Administration, Intravascular
VYGON BIONECTOR WITH EXTENSION SET
| Applicant | Vygon Corp., West Cadwell NJ, US |
| Decision | Substantially Equivalent, Feb 14, 1997 |
| Received | Oct 3, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963981
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 21, 2015 | Churchill Medical Systems, Inc. 6" Trifurcated Extension Set, Product Code: AMS-375-1
Accessory device used to administer medical fluids Terminated |
FPA | None listed |
| Apr 21, 2015 | Churchill Medical Systems, Inc. Bifircated Extension Set, Product Code: BN-828
Accessory device used to administer medical fluids Terminated |
FPA | None listed |
| Apr 21, 2015 | Churchill Medical Systems, Inc. 4" Microbore Double Lumen Set with Bionector, Product Code: BN-208
Accessory device used to administer medical fluids Terminated |
FPA | None listed |
| Apr 21, 2015 | Churchill Medical Systems, Inc. 4" Microbore Trifurcated Ext set, Product Code: BN-308
Accessory device used to administer medical fluids Terminated |
FPA | None listed |
| Apr 21, 2015 | Churchill Medical Systems, Inc. 4" Microbore T-Port Set, Product Code: BN-448
Accessory device used to administer medical fluids Terminated |
FPA | None listed |
| Apr 21, 2015 | Churchill Medical Systems, Inc. 8" Standard Bore Ext Set, Product Code: BN-481
Accessory device used to administer medical fluids Terminated |
FPA | None listed |
| Apr 21, 2015 | Churchill Medical Systems, Inc. 7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1
Accessory device used to administer medical fluids Terminated |
FPA | None listed |
| Apr 21, 2015 | Churchill Medical Systems, Inc. 7" Standard Bore High Pressure Ext Set, Product Code: CMS-809
Accessory device used to administer medical fluids Terminated |
FPA | None listed |
| Apr 21, 2015 | Churchill Medical Systems, Inc. 7" Standard Bore High Pressure Ext Set, Product Code: CMS-809
Accessory device used to administer medical fluids Terminated |
FPA | None listed |
| Apr 21, 2015 | Churchill Medical Systems, Inc. Bifurcated set with check vales and Bionectors, Product Code: BN-2082CV
Accessory device used to administer medical fluids Terminated |
FPA | None listed |
| Apr 21, 2015 | Churchill Medical Systems, Inc. 4" Trifurcated set with Bionectors and check valves, Product Code: BN-3082CV and BN-3083CV
Accessory device used to administer medical fluids Terminated |
FPA | None listed |
| Apr 21, 2015 | Churchill Medical Systems, Inc. 6" Trifurcated set with Bionectors, Product Code: BN-944
Accessory device used to administer medical fluids Terminated |
FPA | None listed |
| Sep 18, 2013 | Churchill Medical Systems, Inc. Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch extension set used to administer IV fluids. Terminated |
FPA | None listed |
| Sep 18, 2013 | Churchill Medical Systems, Inc. Central Dressing Change Kit; AMS-8464CP- 6. Vygon Central Dressing Change Kit contains: 1 Pair Nitrile Gloves W/Wallet, Powderfree 1 Face Mask 1 Polylined Drape, 13" X 18" 1 ChloraPrep***, 3ml Appli Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.