Cleared Traditional

K961917 - MEDTRONIC MUSTANG STEERABLE GUIDE WIRE ...

K961917 is an FDA 510(k) clearance for MEDTRONIC MUSTANG STEERABLE GUIDE WIRE ..., manufactured by Medtronics Interventional Vascular. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K961917 · Medtronics Interventional Vascular · Cardiovascular device
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Nov 1996
Decision
187d
Days
Class 2
Risk

K961917 is an FDA 510(k) clearance for the MEDTRONIC MUSTANG STEERABLE GUIDE WIRE (M-45FR, M45FX). Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Medtronics Interventional Vascular (San Diego, US). The FDA issued a Cleared decision on November 20, 1996 after a review of 187 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronics Interventional Vascular devices

FDA 510(k) Submission Details - K961917

510(k) Number K961917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1996
Decision Date November 20, 1996
Days to Decision 187 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
62d slower than avg
Panel avg: 125d · This submission: 187d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQX Device Classification - Class 2, Special Controls

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 589
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K961917.
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K963702 · Advanced Cardiovascular Systems, Inc. · Jan 1997
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K962572 · Scimed Life Systems, Inc. · Dec 1996
CORDIS ST STEERABLE GUIDEWIRE
K963214 · Cordis Corp. · Nov 1996
CINCH QR SGW EXTENSION
K963171 · Cordis Corp. · Nov 1996
CORDIS STABILIZER PLUS XS
K962932 · Cordis Corp. · Oct 1996