Cleared Traditional

K902587 - SCHNEIDER MONORAIL-GEX(TM) GUIDEWIRE EX...

K902587 is an FDA 510(k) clearance for SCHNEIDER MONORAIL-GEX(TM) GUIDEWIRE EX..., manufactured by Schneider Intl., Ltd.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 174-day FDA review.

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

FDA 510(k) Submission Details - K902587

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.

DQY Device Classification - Class 2, Special Controls

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 601
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K902587.
SOFTOUCH GUIDING CATHETER
K905547 · Mallinckrodt Medical · Feb 1991
VASCULAR RETRIEVAL FORCEPS
K902999 · Cook, Inc. · Feb 1991
ACS URETHAN CORONARY GUIDING CATHETER
K904884 · Advanced Cardiovascular Systems, Inc. · Jan 1991
MALLINCKRODT MEDICAL, INC., INFUSSION CATHERTER
K903330 · Mallinckrodt Medical · Oct 1990
COOK CORONARY GUIDING CATHETER
K902905 · Cook, Inc. · Sep 1990
MANAN ARTERIAL CATHETER NEEDLE
K900978 · Manan Medical Products, Inc. · Aug 1990