V.A.C. FREEDOM CANISTER, MODEL M6275421; V.A.C. ATS CANISTER, MODELS K6275422, M6275423— 510(k) K063590
Substantially EquivalentKci USA, Inc.
FDA 510(k) clearance K063590 for V.A.C. FREEDOM CANISTER, MODEL M6275421; V.A.C. ATS CANISTER, MODELS K6275422, M6275423, Substantially Equivalent on 2007-01-25. Applicant: Kci USA, Inc..
Clearance details
- Applicant
- Kci USA, Inc.
- Product code
- Code OMP
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Antonio, TX, US
Adverse events under product code OMP
product code OMP- Death
- 31
- Injury
- 1,707
- Malfunction
- 4,047
- Other
- 1
- Total
- 5,786
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.