Cleared Traditional

Steerant? Super Stiff Guidewire

K232570 · Medtronic Vascular · Cardiovascular
Oct 2023
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K232570 is an FDA 510(k) clearance for the Steerant? Super Stiff Guidewire, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Medtronic Vascular (Santa Rosa, US). The FDA issued a Cleared decision on October 24, 2023, 61 days after receiving the submission on August 24, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K232570 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 2023
Decision Date October 24, 2023
Days to Decision 61 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQX — Wire, Guide, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1330

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