Atlas FDA

VYGON BIONECTOR WITH EXTENSION SET

FDA 510(k) clearance K963981 · decided 1997-02-14

Clearance details

K-number
K963981
Device name
VYGON BIONECTOR WITH EXTENSION SET
Applicant
Vygon Corp.
Decision
Substantially Equivalent
Date received
1996-10-03
Decision date
1997-02-14
Days to decision
134 days
Clearance type
Traditional
Product code
FPA
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
West Cadwell, NJ, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Vygon Corp.

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
iiSure Infusion Set (K261530)Deka Research and Development2026-06-03
AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04) (K252543)Amsino International, Inc.2026-05-04
PuraCath Firefly Needleless Connector IT (9005) (K251375)Puracath Medical, Inc.2026-02-12
nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727] (K251257)Np Medical2025-12-04
BD Alaris Pump Infusion Set (K250325)Carefusion (Bd)2025-10-30
EZ™ IV Administration Set (K251814)Epic Medical Pte. , Ltd.2025-08-29
SteadiSet infusion set (K251854)Tandem Diabetes Care2025-08-06
Sparta Infusion Set for Insulin (K243841)Deka Research and Development2025-08-01
Infusomat® Space Volumetric Infusion Pump Administration Sets (K243392)B.Braun Medical, Inc.2025-07-24
Clave™ Neutral-Displacement Needlefree Connectors (K250616)Icu Medical, Inc.2025-06-05
SteadiSet Infusion Set (K242692)Capillary Biomedical, LLC2025-05-09
JetCan® Pro Safety Huber Needle (K242763)Pfm Medical, Inc.2025-05-02

Recalls involving this device

RecordFirmDate
6" Trifurcated Extension Set, Product Code: AMS-375-1 Accessory device used to administer recall (Z-1467-2015)Churchill Medical Systems, Inc.2015-04-21
Bifircated Extension Set, Product Code: BN-828 Accessory device used to administer medical recall (Z-1468-2015)Churchill Medical Systems, Inc.2015-04-21
4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory device used t recall (Z-1469-2015)Churchill Medical Systems, Inc.2015-04-21
4" Microbore Trifurcated Ext set, Product Code: BN-308 Accessory device used to administer recall (Z-1470-2015)Churchill Medical Systems, Inc.2015-04-21
4" Microbore T-Port Set, Product Code: BN-448 Accessory device used to administer medical recall (Z-1471-2015)Churchill Medical Systems, Inc.2015-04-21
8" Standard Bore Ext Set, Product Code: BN-481 Accessory device used to administer medical recall (Z-1472-2015)Churchill Medical Systems, Inc.2015-04-21
7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1 Accessory device recall (Z-1473-2015)Churchill Medical Systems, Inc.2015-04-21
7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to adm recall (Z-1474-2015)Churchill Medical Systems, Inc.2015-04-21
7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to adm recall (Z-1475-2015)Churchill Medical Systems, Inc.2015-04-21
Bifurcated set with check vales and Bionectors, Product Code: BN-2082CV Accessory device u recall (Z-1476-2015)Churchill Medical Systems, Inc.2015-04-21
4" Trifurcated set with Bionectors and check valves, Product Code: BN-3082CV and BN-3083CV recall (Z-1477-2015)Churchill Medical Systems, Inc.2015-04-21
6" Trifurcated set with Bionectors, Product Code: BN-944 Accessory device used to administ recall (Z-1478-2015)Churchill Medical Systems, Inc.2015-04-21
Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch ext recall (Z-2251-2013)Churchill Medical Systems, Inc.2013-09-18
Central Dressing Change Kit; AMS-8464CP- 6. Vygon Central Dressing Change Kit contains: 1 recall (Z-2252-2013)Churchill Medical Systems, Inc.2013-09-18