The following data is part of a premarket notification filed by Peca Labs with the FDA for Exgraft Eptfe Vascular Graft, Exgraft Carbon Eptfe Vascular Graft.
| Device ID | K202471 |
| 510k Number | K202471 |
| Device Name: | ExGraft EPTFE Vascular Graft, ExGraft Carbon EPTFE Vascular Graft |
| 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 | 2020-08-28 |
| Decision Date | 2020-12-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818136020881 | K202471 | 000 |
| 00818136020850 | K202471 | 000 |
| 00818136020812 | K202471 | 000 |