510(k) K140306
K140306 is an FDA 510(k) premarket notification submitted by Cormatrix Cardiovascular, Inc. for the device "CORMATRIX PROTECT ECM ENVELOPE". The FDA issued a decision of Substantially Equivalent on August 15, 2014. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Cormatrix Cardiovascular, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 15, 2014
- Date Received
- February 7, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type