The following data is part of a premarket notification filed by Vascutech, Inc. with the FDA for Lemaitre Balloon Catheter With Irrigation.
| Device ID | K992940 |
| 510k Number | K992940 |
| Device Name: | LEMAITRE BALLOON CATHETER WITH IRRIGATION |
| Classification | Catheter, Embolectomy |
| Applicant | VASCUTECH, INC. 164 MIDDLESEX TURNPIKE Burlington, MA 01803 |
| Contact | Trent G Kamke |
| Correspondent | Trent G Kamke VASCUTECH, INC. 164 MIDDLESEX TURNPIKE Burlington, MA 01803 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-31 |
| Decision Date | 2000-02-22 |