MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039— 510(k) K070705
Substantially EquivalentVygon Corp.
FDA 510(k) clearance K070705 for MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039, Substantially Equivalent on 2007-11-30. Applicant: Vygon Corp.. Device class: 2.
Clearance details
- Applicant
- Vygon Corp.
- Product code
- Code FOZ
- Device class
- Class 2
- Regulation
- 21 CFR 880.5200
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Norristown, PA, US
Recent devices under product code FOZ
view allMore clearances from Vygon Corp.
view allAdverse events under product code FOZ
product code FOZ- Death
- 38
- Injury
- 2,290
- Malfunction
- 25,858
- Other
- 11
- Total
- 28,197
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 K070705
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-0113-2015 — 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 medications to patients in a hospital or homecare situation.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K070705.
Data sourced from openFDA. This site is unofficial and independent of the FDA.