The following data is part of a premarket notification filed by Lemaitre Vascular, Inc. with the FDA for 1.5mm Hydro Expandable Lemaitre Valvulotome.
| Device ID | K140042 |
| 510k Number | K140042 |
| Device Name: | 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME |
| Classification | Valvulotome |
| Applicant | LEMAITRE VASCULAR, INC. 63 SECOND AVENUE Burlington, MA 01803 |
| Contact | Bryan Cowell |
| Correspondent | Bryan Cowell 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 | 2014-01-08 |
| Decision Date | 2014-04-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840663106837 | K140042 | 000 |
| 00840663106820 | K140042 | 000 |
| 00840663106660 | K140042 | 000 |
| 00840663106653 | K140042 | 000 |