The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Trapliner Catheter.
Device ID | K161901 |
510k Number | K161901 |
Device Name: | TrapLiner Catheter |
Classification | Catheter, Percutaneous |
Applicant | Vascular Solutions, Inc. 6464 Sycamore Court North Minneapolis, MN 55369 |
Contact | Beka Vite |
Correspondent | Beka Vite Vascular Solutions, Inc. 6464 Sycamore Court North Minneapolis, MN 55369 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-07-11 |
Decision Date | 2017-02-03 |
Summary: | summary |