The following data is part of a premarket notification filed by Tisgenx with the FDA for Bovine Pericardial Tissue Patch.
| Device ID | K182493 |
| 510k Number | K182493 |
| Device Name: | Bovine Pericardial Tissue Patch |
| Classification | Mesh, Surgical |
| Applicant | Tisgenx 15615 Alton Parkway, Suite 450 Irvine, CA 92618 |
| Contact | Kris Kupumbati |
| Correspondent | Kris Kupumbati Tisgenx 15615 Alton Parkway, Suite 450 Irvine, CA 92618 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-11 |
| Decision Date | 2019-06-18 |