Cleared Traditional

MAGNUM-MEIER RECANALIZATION GUIDEWIRE (K911547) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K911547 · Schneider Intl., Ltd. · Cardiovascular device
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Jul 1991
Decision
88d
Days
Class 2
Risk

K911547 is an FDA 510(k) clearance for the MAGNUM-MEIER RECANALIZATION GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Schneider Intl., Ltd. (Plymouth, US). The FDA issued a Cleared decision on July 5, 1991 after a review of 88 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 Schneider Intl., Ltd. devices

Submission Details

510(k) Number K911547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1991
Decision Date July 05, 1991
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 125d · This submission: 88d
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 225
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K911547.
JAGWIRE(TM) RECANALIZATION GUIDEWIRE
K922302 · Boston Scientific Corp · Jul 1992
DESERET GUIDEWIRE INTRODUCER
K915496 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1992
CORDIS CINCH(R) STEERABLE GUIDEWIRE EXT W/SLX COAT
K914863 · Cordis Corp. · Dec 1991
CORDIS REFLEX STEERABLE GUIDEWIRE
K905423 · Cordis Corp. · Mar 1991
CORDIS CINCH(TM) STEER GUIDEWIRE EXTEN W/SLX COAT
K902612 · Cordis Corp. · Dec 1990
USCI(R) SILK (TM) GUIDE WIRE
K903923 · C.R. Bard, Inc. · Nov 1990