V.A.C. DERMATAC Drape— 510(k) K200390
Substantially EquivalentKci USA, Inc.
FDA 510(k) clearance K200390 for V.A.C. DERMATAC Drape, Substantially Equivalent on 2020-05-18. Applicant: Kci USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Kci USA, Inc.
- Product code
- Product code OMP
- Device class
- Class 2
- Regulation
- 21 CFR 878.4780
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Antonio, TX, US
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More clearances from Kci USA, Inc.
view all- K241134 — 3M ActiV.A.C. Canister - 300ml with Gel (M8275058/5, M8275058/10)
- K201571 — ACTIV.A.C. Negative Pressure Wound Therapy System
- K190697 — PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag)
- DEN180013 — PREVENA 125 and PREVENA PLUS 125 Therapy Units
- K181505 — V.A.C. DERMATAC Drape
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.