FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
V.A.C. THERAPY SYSTEMS - INFO V.A.C. THERAPY UNIY, MODEL M6257766
K Number: K063740
·
Decision Jun 7, 2007
Classifications
1
FEI Numbers
105
Registration Numbers
105
Same Product Code
211
Applicant Total
28
Review Days
171
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Basic Information
- Device Name
- V.A.C. THERAPY SYSTEMS - INFO V.A.C. THERAPY UNIY, MODEL M6257766
- K Number
- K063740
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4780
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kci USA, Inc.
- Date Received
- December 18, 2006
- Decision Date
- June 7, 2007
- Product Code
- OMP
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Kci USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K241134 | 3M ActiV.A.C. Canister - 300ml with Gel (M8275058/5, M8275058/10) | May 23, 2024 | Substantially Equivalent |
| K201571 | ACTIV.A.C. Negative Pressure Wound Therapy System | Jul 8, 2020 | Substantially Equivalent |
| K200390 | V.A.C. DERMATAC Drape | May 18, 2020 | Substantially Equivalent |
| K190697 | PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag) | Nov 22, 2019 | Substantially Equivalent |
| DEN180013 | PREVENA 125 and PREVENA PLUS 125 Therapy Units | Apr 19, 2019 | Unknown |
| K181505 | V.A.C. DERMATAC Drape | Mar 28, 2019 | Substantially Equivalent |
| K183543 | ACTIV.A.C. Therapy Unit | Mar 20, 2019 | Substantially Equivalent |
| K181507 | PREVENA RESTOR(TM) Incision Management System | Feb 15, 2019 | Substantially Equivalent |
| K180855 | Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System | Jun 1, 2018 | Substantially Equivalent |
| K173426 | PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System | Mar 9, 2018 | Substantially Equivalent |