Bovine Pericardium Patch
FDA 510(k) K141721 · Collafirm, LLC
510(k) numberK141721
Submission
- Device name
- Bovine Pericardium Patch
- Applicant
- Collafirm, LLC
Monmouth Jct, NJ, US - Received
- June 25, 2014
- Decision date
- December 22, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FTM – Mesh, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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Questions and answers
When was Bovine Pericardium Patch cleared by the FDA?
Bovine Pericardium Patch (K141721) received a 510(k) decision of Substantially Equivalent on December 22, 2014, 180 days after the submission was received.
What is the product code of K141721?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.