V.A.C. THERAPY SYSTEMS - INFO V.A.C. THERAPY UNIY, MODEL M6257766
FDA 510(k) clearance K063740 · decided 2007-06-07
Clearance details
- K-number
- K063740
- Device name
- V.A.C. THERAPY SYSTEMS - INFO V.A.C. THERAPY UNIY, MODEL M6257766
- Applicant
- Kci USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-12-18
- Decision date
- 2007-06-07
- Days to decision
- 171 days
- Clearance type
- Traditional
- Product code
- OMP
- Device class
- 2
- Regulation number
- 878.4780
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Antonio, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. recall (Z-0666-2010) | KCI USA, Inc. | 2010-01-25 |
| 500 mL InfoV.A.C. Canisters (with Gel); Part #M8275063/5 (5 canister pack) and Part #M8275 recall (Z-2439-2008) | KCI USA, Inc. | 2008-09-20 |
| 500 mL InfoV.A.C. Canister (without Gel); Part #M8275071/5 (5 canister pack) and Part #M82 recall (Z-2440-2008) | KCI USA, Inc. | 2008-09-20 |