The following data is part of a premarket notification filed by Lemaitre Vascular, Inc. with the FDA for Lemills Valvulotome.
| Device ID | K132047 |
| 510k Number | K132047 |
| Device Name: | LEMILLS VALVULOTOME |
| Classification | Valvulotome |
| Applicant | LEMAITRE VASCULAR, INC. 63 SECOND AVENUE Burlington, MA 01803 |
| Contact | Andrew Hodgkinson |
| Correspondent | Andrew Hodgkinson LEMAITRE VASCULAR, INC. 63 SECOND AVENUE Burlington, MA 01803 |
| Product Code | MGZ |
| CFR Regulation Number | 870.4885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-02 |
| Decision Date | 2013-11-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840663107360 | K132047 | 000 |
| 00840663107353 | K132047 | 000 |
| 00840663107346 | K132047 | 000 |
| 00840663107339 | K132047 | 000 |
| 00840663107322 | K132047 | 000 |
| 00840663107315 | K132047 | 000 |