Cleared Traditional

SCHNEIDER MAGNUM PERIPHERAL RECANAL GUIDEWIRE (K912156) - FDA 510(k) Clearance

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

K912156 · Schneider Intl., Ltd. · Cardiovascular device
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Sep 1991
Decision
115d
Days
Class 2
Risk

K912156 is an FDA 510(k) clearance for the SCHNEIDER MAGNUM PERIPHERAL RECANAL 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 September 6, 1991 after a review of 115 days - within the typical 510(k) review window.

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 Schneider Intl., Ltd. devices

Submission Details

510(k) Number K912156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1991
Decision Date September 06, 1991
Days to Decision 115 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 125d · This submission: 115d
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 K912156.
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