Cleared Traditional

SCHNEIDER MONORAIL-GEX(TM) GUIDEWIRE EXCHANGE CATH (K902587) - FDA 510(k) Clearance

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

K902587 · Schneider Intl., Ltd. · Cardiovascular device
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Dec 1990
Decision
174d
Days
Class 2
Risk

K902587 is an FDA 510(k) clearance for the SCHNEIDER MONORAIL-GEX(TM) GUIDEWIRE EXCHANGE CATH. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Schneider Intl., Ltd. (Plymouth, US). The FDA issued a Cleared decision on December 3, 1990 after a review of 174 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 K902587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1990
Decision Date December 03, 1990
Days to Decision 174 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 125d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 293
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K902587.
CORDIS 7 FRENCH 0.072 I.D. PTCA GUIDING CATHETER
K912777 · Cordis Corp. · Sep 1991
NEW USCI 7F PTCA GUIDING CATHETER
K905249 · C.R. Bard, Inc. · Feb 1991
VASCULAR RETRIEVAL FORCEPS
K902999 · Cook, Inc. · Feb 1991
COOK CORONARY GUIDING CATHETER
K902905 · Cook, Inc. · Sep 1990
USCI UNCOATED GUIDING CATHETERS
K894682 · C.R. Bard, Inc. · Sep 1989
USCI PROBING CATHETER
K890152 · C.R. Bard, Inc. · Aug 1989