510(k) K182570

Venture 0.014 Catheter by Vascular Solutions, LLC — Product Code DQY

K182570 is an FDA 510(k) premarket notification submitted by Vascular Solutions, LLC for the device "Venture 0.014 Catheter". The FDA issued a decision of Substantially Equivalent on March 13, 2019. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Vascular Solutions, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2019
Date Received
September 18, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type