PUNCTURE KIT, DISPOSALBE VEIN
FDA 510(k) clearance K781978 · decided 1978-12-12
Clearance details
- K-number
- K781978
- Device name
- PUNCTURE KIT, DISPOSALBE VEIN
- Applicant
- Arrow Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-11-27
- Decision date
- 1978-12-12
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- FMF
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Description/REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20 CM)/AK-04300, recall (Z-2396-2026) | ARROW INTERNATIONAL, LLC | 2026-06-13 |