3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG)
by 3M Healthcare Business Group
510(k) K211521
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK211521 | Date20 Dec 2021 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- OMP
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4780
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
The Veraflo Cleanse Choice Complete Dressing Kit is a negative pressure wound therapy powered suction pump accessory designed to facilitate wound cleansing. It is used in conjunction with Veraflo therapy to initiate the hydromechanical removal of infectious materials, non-viable tissue, and wound debris while promoting granulation tissue growth.
This device is available in medium (VFCCC05MD) and large (VFCCC05LG) dressing kit sizes to accommodate varying wound types. The kit features a single-layer foam and is authorized under FDA 510(k) clearance.
Other devices from 3M Healthcare Business Group
Questions
AI-generated answers, 24 Sep 2026
What is the primary purpose of the Veraflo Cleanse Choice Complete Dressing Kit?
This device is a negative pressure wound therapy suction pump accessory used to facilitate wound cleansing. It works in conjunction with Veraflo therapy to assist in the hydromechanical removal of wound debris, non-viable tissue, and infectious materials while supporting the growth of granulation tissue.
What sizes are available for this dressing kit?
The kit is available in two sizes to accommodate different wound types: a medium dressing kit (VFCCC05MD) and a large dressing kit (VFCCC05LG).
What are the key components of the dressing kit?
The kit features a single-layer foam design specifically engineered to function as part of a negative pressure wound therapy system for effective wound management.
Is this device authorized for use?
Yes, the 3M Veraflo Cleanse Choice Complete Dressing Kit is authorized under FDA 510(k) clearance.