VIASPAN (BELZER UW - CSS)
FDA 510(k) clearance K944866 · decided 1996-04-22
Clearance details
- K-number
- K944866
- Device name
- VIASPAN (BELZER UW - CSS)
- Applicant
- The Dupont Merck Pharmaceutical Co.
- Decision
- Substantially Equivalent
- Date received
- 1994-10-03
- Decision date
- 1996-04-22
- Days to decision
- 567 days
- Clearance type
- Traditional
- Product code
- KDL
- Device class
- 2
- Regulation number
- 876.5880
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Wilmington, DE, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ViaSpan Cold Storage Solution 1000mL Bag distributed under the Barr/Duramed Pharmaceutical recall (Z-1437-2012) | Teva Pharmaceuticals USA, Inc. | 2012-04-18 |