510(k) K232570

Steerant™ Super Stiff Guidewire by Medtronic Vascular — Product Code DQX

K232570 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "Steerant™ Super Stiff Guidewire". The FDA issued a decision of Substantially Equivalent on October 24, 2023. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Medtronic Vascular has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2023
Date Received
August 24, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
Review Panel
CV
Submission Type