The following data is part of a premarket notification filed by Peca Labs with the FDA for Exgraft, Exgraft Carbon Eptfe Vascular Grafts.
| Device ID | K180957 |
| 510k Number | K180957 |
| Device Name: | ExGraft, ExGraft Carbon EPTFE Vascular Grafts |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | PECA Labs 4424 Penn Ave, Suite 201 Pittsburgh, PA 15224 |
| Contact | Doug Bernstein |
| Correspondent | Doug Bernstein PECA Labs 4424 Penn Ave, Suite 201 Pittsburgh, PA 15224 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-12 |
| Decision Date | 2018-08-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818136021147 | K180957 | 000 |
| 00818136020577 | K180957 | 000 |
| 00818136020607 | K180957 | 000 |
| 00818136020614 | K180957 | 000 |
| 00818136020645 | K180957 | 000 |
| 00818136020652 | K180957 | 000 |
| 00818136020683 | K180957 | 000 |
| 00818136020690 | K180957 | 000 |
| 00818136020720 | K180957 | 000 |
| 00818136020737 | K180957 | 000 |
| 00818136020669 | K180957 | 000 |
| 00818136020706 | K180957 | 000 |
| 00818136020461 | K180957 | 000 |
| 00818136020621 | K180957 | 000 |
| 00818136020980 | K180957 | 000 |
| 00818136020584 | K180957 | 000 |
| 00818136020560 | K180957 | 000 |