The following data is part of a premarket notification filed by Edwards Lifesciences, Llc with the FDA for Duravess Bovine Pericardial Vascular Patch.
| Device ID | K172660 |
| 510k Number | K172660 |
| Device Name: | Duravess Bovine Pericardial Vascular Patch |
| Classification | Intracardiac Patch Or Pledget, Biologically Derived |
| Applicant | Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614 |
| Contact | Christine Chun |
| Correspondent | Christine Chun Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614 |
| Product Code | PSQ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-05 |
| Decision Date | 2017-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103199048 | K172660 | 000 |
| 00690103199031 | K172660 | 000 |
| 00690103199024 | K172660 | 000 |