The following data is part of a premarket notification filed by Vascutech, Inc. with the FDA for 2.0mm Expandable Lemaitre Valvulotome (elv 2.0- Gnt).
| Device ID | K980723 |
| 510k Number | K980723 |
| Device Name: | 2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT) |
| Classification | Valvulotome |
| Applicant | VASCUTECH, INC. 164 MIDDLESEX TURNPIKE Burlington, MA 01803 |
| Contact | George W Lemaitre |
| Correspondent | George W Lemaitre VASCUTECH, INC. 164 MIDDLESEX TURNPIKE 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 | 1998-02-24 |
| Decision Date | 1999-02-12 |