3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit— 510(k) K221585
Substantially Equivalent3M Healthcare Business Group
FDA 510(k) clearance K221585 for 3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit, Substantially Equivalent on 2023-03-23. Applicant: 3M Healthcare Business Group. Device class: 2.
Clearance details
- Applicant
- 3M Healthcare Business Group
- Product code
- 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
Recent devices under product code OMP
view allMore clearances from 3M Healthcare Business Group
view all- K220660 — Prevena Restor Adapti-Form Dressing
- K210135 — PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing
- K211521 — 3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG)
- K212320 — Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Small (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology - Medium(5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Medium (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology- Large (5 pac
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.