VYGON BIONECTOR WITH EXTENSION SET— 510(k) K963981
Substantially EquivalentVygon Corp.
FDA 510(k) clearance K963981 for VYGON BIONECTOR WITH EXTENSION SET, Substantially Equivalent on 1997-02-14. Applicant: Vygon Corp.. Device class: 2.
Clearance details
- Applicant
- Vygon Corp.
- Product code
- Code FPA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Cadwell, NJ, US
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More clearances from Vygon Corp.
view allAdverse events under product code FPA
product code FPA- Death
- 95
- Injury
- 14,421
- Malfunction
- 125,815
- Other
- 30
- Total
- 140,361
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K963981
K-number listed on FDA's recall record- Z-1467-2015 — 6" Trifurcated Extension Set, Product Code: AMS-375-1 Accessory device used to administer medical fluids
- Z-1468-2015 — Bifircated Extension Set, Product Code: BN-828 Accessory device used to administer medical fluids
- Z-1469-2015 — 4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory device used to administer medical fluids
- Z-1470-2015 — 4" Microbore Trifurcated Ext set, Product Code: BN-308 Accessory device used to administer medical fluids
- Z-1471-2015 — 4" Microbore T-Port Set, Product Code: BN-448 Accessory device used to administer medical fluids
- Z-1472-2015 — 8" Standard Bore Ext Set, Product Code: BN-481 Accessory device used to administer medical fluids
- Z-1473-2015 — 7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1 Accessory device used to administer medical fluids
- Z-1474-2015 — 7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer medical fluids
- Z-1475-2015 — 7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer medical fluids
- Z-1476-2015 — Bifurcated set with check vales and Bionectors, Product Code: BN-2082CV Accessory device used to administer medical fluids
- Z-1477-2015 — 4" Trifurcated set with Bionectors and check valves, Product Code: BN-3082CV and BN-3083CV Accessory device used to administer medical fluids
- Z-1478-2015 — 6" Trifurcated set with Bionectors, Product Code: BN-944 Accessory device used to administer medical fluids
- Z-2251-2013 — 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.
- Z-2252-2013 — 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 Applicator W/Insert 1 Pkg. Alcohol Swabsticks (3/Pkg.) 1 14" Extension Set W/Bionector*** 2 Dressing Sponges, 2" X 2" 1 Foam Strip, 8/5cm X 1cm 1 3M*** Tegaderm *** IV Dressing W/CHG, 2 1/2" X 4 1/2" *** Vygon MFG Dover, NH 03820***"
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K963981.
Data sourced from openFDA. This site is unofficial and independent of the FDA.