Cleared Traditional

K912156 - SCHNEIDER MAGNUM PERIPHERAL RECANAL GUI...

K912156 is an FDA 510(k) clearance for SCHNEIDER MAGNUM PERIPHERAL RECANAL GUI..., manufactured by Schneider Intl., Ltd.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 115-day FDA review.

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

FDA 510(k) Submission Details - K912156

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.

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 522
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K912156.
ACS VSW GUIDE WIRE
K913178 · Advanced Cardiovascular Systems, Inc. · Oct 1991
AMPLANTZ AND BENTSON GUIDEWIRES
K912798 · Meadox Medicals, Div. Boston Scientific Corp. · Sep 1991
OPEN ENDED GUIDEWIRE
K912878 · Lake Region Mfg., Inc. · Sep 1991
.010 HI-TORQUE GUIDE WIRES WITH PRESHAPED TIP
K911460 · Advanced Cardiovascular Systems, Inc. · Jun 1991
CORDIS REFLEX STEERABLE GUIDEWIRE
K905423 · Cordis Corp. · Mar 1991
PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY GUIDEWIRE
K905548 · Mallinckrodt Medical · Feb 1991