The following data is part of a premarket notification filed by Lemaitre Vascular, Inc. with the FDA for Over-the-wire Expandable Lemaitre Valvulotome.
| Device ID | K111884 |
| 510k Number | K111884 |
| Device Name: | OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME |
| Classification | Valvulotome |
| 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 | MGZ |
| CFR Regulation Number | 870.4885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-01 |
| Decision Date | 2011-07-29 |
| Summary: | summary |