MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS
FDA 510(k) clearance K032310 · decided 2003-10-10
Clearance details
- K-number
- K032310
- Device name
- MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS
- Applicant
- Kinetic Concepts, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-07-28
- Decision date
- 2003-10-10
- Days to decision
- 74 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 |
|---|---|---|
| V.A.C. ATS Canister with Gel (500 mL), Part #M6275063/10.S, distributed by Kinetic Concept recall (Z-0379-06) | Kinetic Concepts, Inc | 2006-01-11 |
| V.A.C. X-Large Granufoam Dressing Part Numbers M6275065/5, V.A.C. ATS and V.A.C. Freedom a recall (Z-0038-05) | Kinetic Concepts, Inc | 2004-10-22 |