The following data is part of a premarket notification filed by Lemaitre Vascular, Inc. with the FDA for Albograft Vascular Prosthesis.
| Device ID | K103080 |
| 510k Number | K103080 |
| Device Name: | ALBOGRAFT VASCULAR PROSTHESIS |
| Classification | Graft, Vascular, Synthetic/biologic Composite |
| Applicant | LEMAITRE VASCULAR, INC. 63 2ND AVENUE Burlington, MA 01803 |
| Contact | Andrew Hodgkinson |
| Correspondent | Andrew Hodgkinson LEMAITRE VASCULAR, INC. 63 2ND AVENUE Burlington, MA 01803 |
| Product Code | MAL |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-19 |
| Decision Date | 2011-01-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840663110353 | K103080 | 000 |