The following data is part of a premarket notification filed by Vascutech, Inc. with the FDA for Lemaitre Biliary Catheter.
Device ID | K992941 |
510k Number | K992941 |
Device Name: | LEMAITRE BILIARY CATHETER |
Classification | Dislodger, Stone, Biliary |
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 | LQR |
CFR Regulation Number | 876.5010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-08-31 |
Decision Date | 2000-01-12 |