510(k) K070705 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039
| Applicant | Vygon Corp., Norristown PA, US |
| Decision | Substantially Equivalent, Nov 30, 2007 |
| Received | Mar 14, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070705
| 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 |
| Oct 22, 2014 | Vygon Corporation Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed needle-less system permitting blood sampling, intermit ant injection and continuous infusion of fluids or medi Terminated |
FOZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.