The following data is part of a premarket notification filed by Lemaitre Vascular, Inc. with the FDA for Antegrade Lemills Valvulotome.
| Device ID | K142660 |
| 510k Number | K142660 |
| Device Name: | Antegrade LeMills Valvulotome |
| Classification | Valvulotome |
| Applicant | LeMaitre Vascular, Inc. 63 Second Avenue Burlington, MA 01803 |
| Contact | Xiang (vic) Zhang |
| Correspondent | Anna Kasseris LeMaitre Vascular, Inc. 63 Second Avenue Burlington, MA 01803 |
| Product Code | MGZ |
| CFR Regulation Number | 870.4885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-18 |
| Decision Date | 2014-10-17 |
| Summary: | summary |