The following data is part of a premarket notification filed by Lemaitre Vascular, Inc. with the FDA for Albosure Polyester Vascular Patch.
| Device ID | K101740 |
| 510k Number | K101740 |
| Device Name: | ALBOSURE POLYESTER VASCULAR PATCH |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | LEMAITRE VASCULAR, INC. 63 2ND AVENUE Burlington, MA 01803 |
| Contact | Vic Zhang |
| Correspondent | Vic Zhang LEMAITRE VASCULAR, INC. 63 2ND AVENUE Burlington, MA 01803 |
| Product Code | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-21 |
| Decision Date | 2010-09-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840663105021 | K101740 | 000 |
| 00840663104895 | K101740 | 000 |
| 00840663104802 | K101740 | 000 |
| 00840663104765 | K101740 | 000 |
| 00840663104604 | K101740 | 000 |
| 00840663104543 | K101740 | 000 |