510(k) K210647

SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter by Vascular Solutions, LLC — Product Code DQY

K210647 is an FDA 510(k) premarket notification submitted by Vascular Solutions, LLC for the device "SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter". The FDA issued a decision of Substantially Equivalent on April 30, 2021. 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
April 30, 2021
Date Received
March 3, 2021
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