V.A.C. THERAPY SYSTEM
FDA 510(k) clearance K062227 · decided 2006-10-04
Clearance details
- K-number
- K062227
- Device name
- V.A.C. THERAPY SYSTEM
- Applicant
- Kci USA, Inc. (Kinetic Concepts, Inc.)
- Decision
- Substantially Equivalent
- Date received
- 2006-08-02
- Decision date
- 2006-10-04
- Days to decision
- 63 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 |
|---|---|---|
| 3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7 D recall (Z-1176-2025) | KCI USA, INC. | 2025-02-14 |
| AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. recall (Z-0666-2010) | KCI USA, Inc. | 2010-01-25 |