ClearanceBrief
510(k) K963981 ยท FPA Set, Administration, Intravascular

VYGON BIONECTOR WITH EXTENSION SET

ApplicantVygon Corp., West Cadwell NJ, US
DecisionSubstantially Equivalent, Feb 14, 1997
ReceivedOct 3, 1996
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K963981

DateFirm and productCodeLinked 510(k)
Apr 21, 2015Churchill Medical Systems, Inc.
6" Trifurcated Extension Set, Product Code: AMS-375-1 Accessory device used to administer medical fluids
Terminated
FPANone listed
Apr 21, 2015Churchill Medical Systems, Inc.
Bifircated Extension Set, Product Code: BN-828 Accessory device used to administer medical fluids
Terminated
FPANone listed
Apr 21, 2015Churchill Medical Systems, Inc.
4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory device used to administer medical fluids
Terminated
FPANone listed
Apr 21, 2015Churchill Medical Systems, Inc.
4" Microbore Trifurcated Ext set, Product Code: BN-308 Accessory device used to administer medical fluids
Terminated
FPANone listed
Apr 21, 2015Churchill Medical Systems, Inc.
4" Microbore T-Port Set, Product Code: BN-448 Accessory device used to administer medical fluids
Terminated
FPANone listed
Apr 21, 2015Churchill Medical Systems, Inc.
8" Standard Bore Ext Set, Product Code: BN-481 Accessory device used to administer medical fluids
Terminated
FPANone listed
Apr 21, 2015Churchill 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
FPANone listed
Apr 21, 2015Churchill Medical Systems, Inc.
7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer medical fluids
Terminated
FPANone listed
Apr 21, 2015Churchill Medical Systems, Inc.
7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer medical fluids
Terminated
FPANone listed
Apr 21, 2015Churchill Medical Systems, Inc.
Bifurcated set with check vales and Bionectors, Product Code: BN-2082CV Accessory device used to administer medical fluids
Terminated
FPANone listed
Apr 21, 2015Churchill 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
FPANone listed
Apr 21, 2015Churchill Medical Systems, Inc.
6" Trifurcated set with Bionectors, Product Code: BN-944 Accessory device used to administer medical fluids
Terminated
FPANone listed
Sep 18, 2013Churchill 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
FPANone listed
Sep 18, 2013Churchill 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
FPANone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.