V.A.C. THERAPY SYSTEMS-ACTI V.A.C. THERAPY UNIT MODEL# 340000
FDA 510(k) clearance K063692 · decided 2007-06-07
Clearance details
- K-number
- K063692
- Device name
- V.A.C. THERAPY SYSTEMS-ACTI V.A.C. THERAPY UNIT MODEL# 340000
- Applicant
- Kci USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-12-13
- Decision date
- 2007-06-07
- Days to decision
- 176 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
+ Add to Predicate Builder ◉ Watch Kci USA
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. recall (Z-0665-2010) | KCI USA, Inc. | 2010-01-25 |