510(k) K172660
K172660 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences, LLC for the device "Duravess bovine pericardial vascular patch". The FDA issued a decision of Substantially Equivalent on November 17, 2017. The device falls under product code PSQ (Intracardiac Patch Or Pledget, Biologically Derived), a Class II device regulated under 21 CFR 870.3470. Edwards Lifesciences, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 17, 2017
- Date Received
- September 5, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intracardiac Patch Or Pledget, Biologically Derived
- Device Class
- Class II
- Regulation Number
- 870.3470
- Review Panel
- CV
- Submission Type
To repair defects, to be used for patch grafting, to repair tissue, and to buttress sutures in the heart and vasculature.