The following data is part of a premarket notification filed by Lemaitre Vascular with the FDA for Eze Sit Valvulotome.
| Device ID | K190267 |
| 510k Number | K190267 |
| Device Name: | EZE SIT Valvulotome |
| Classification | Valvulotome |
| Applicant | LeMaitre Vascular 63 Second Avenue Burlington, MA 01803 |
| Contact | John N. Bradsher |
| Correspondent | John N. Bradsher LeMaitre Vascular 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 | 2019-02-08 |
| Decision Date | 2019-10-30 |
| Summary: | summary |