The following data is part of a premarket notification filed by Lemaitre Vascular with the FDA for Xenosure Biologic Patch.
| Device ID | K190882 |
| 510k Number | K190882 |
| Device Name: | XenoSure Biologic Patch |
| Classification | Intracardiac Patch Or Pledget, Biologically Derived |
| Applicant | LeMaitre Vascular 63 Second Avenue Burlington, MA 01803 |
| Contact | John N. Bradsher |
| Correspondent | John N. Bradsher LeMaitre Vascular 63 Second Avenue Burlington, MA 01803 |
| Product Code | PSQ |
| Subsequent Product Code | FTM |
| Subsequent Product Code | MFX |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-04 |
| Decision Date | 2020-02-13 |