The following data is part of a premarket notification filed by Peca Labs with the FDA for Exgraft, Exgraft Carbon.
| Device ID | K183613 |
| 510k Number | K183613 |
| Device Name: | ExGraft, ExGraft Carbon |
| 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 | 2018-12-26 |
| Decision Date | 2019-04-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818136023257 | K183613 | 000 |
| 00818136023226 | K183613 | 000 |
| 00818136022984 | K183613 | 000 |
| 00818136022946 | K183613 | 000 |
| 00818136022786 | K183613 | 000 |
| 00818136022700 | K183613 | 000 |
| 00818136022663 | K183613 | 000 |
| 00818136020775 | K183613 | 000 |