Cleared Traditional

K232570 - Steerant Super Stiff Guidewire

K232570 is the FDA 510(k) clearance for Steerant Super Stiff Guidewire by Medtronic Vascular. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K232570 · Medtronic Vascular · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Oct 2023
Decision
61d
Days
Class 2
Risk

K232570 is an FDA 510(k) clearance for the Steerant™ Super Stiff Guidewire. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Medtronic Vascular (Santa Rosa, US). The FDA issued a Cleared decision on October 24, 2023 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic Vascular devices

Submission Details

510(k) Number K232570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 125d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQX Wire, Guide, Catheter

All 498
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