The following data is part of a premarket notification filed by Vascular Solutions, Llc with the FDA for Venture 0.014 Catheter.
Device ID | K182570 |
510k Number | K182570 |
Device Name: | Venture 0.014 Catheter |
Classification | Catheter, Percutaneous |
Applicant | Vascular Solutions, LLC 6464 Sycamore Court North Minneapolis, MN 55369 |
Contact | Becky Astrup |
Correspondent | Becky Astrup Vascular Solutions, LLC 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 | 2018-09-18 |
Decision Date | 2019-03-13 |