Cleared Traditional

K902612 - CORDIS CINCH(TM) STEER GUIDEWIRE EXTEN ...

K902612 is an FDA 510(k) clearance for CORDIS CINCH(TM) STEER GUIDEWIRE EXTEN ..., manufactured by Cordis Corp.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K902612 · Cordis Corp. · Cardiovascular device
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Dec 1990
Decision
173d
Days
Class 2
Risk

K902612 is an FDA 510(k) clearance for the CORDIS CINCH(TM) STEER GUIDEWIRE EXTEN W/SLX COAT. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Cordis Corp. (Miami, US). The FDA issued a Cleared decision on December 3, 1990 after a review of 173 days - an extended review 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: 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 Cordis Corp. devices

FDA 510(k) Submission Details - K902612

510(k) Number K902612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1990
Decision Date December 03, 1990
Days to Decision 173 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 125d · This submission: 173d
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 541
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K902612.
.010 HI-TORQUE FLOPPY GUIDE WIRE W/PRESHAPED TIP
K905502 · Advanced Cardiovascular Systems, Inc. · Feb 1991
DATASCOPE INTERLOCK GUIDE WIRE EXTENSION
K905432 · Datascope Corp. · Jan 1991
GUIDEWIRE
K904477 · Datascope Corp. · Dec 1990
USCI(R) SILK (TM) GUIDE WIRE
K903923 · C.R. Bard, Inc. · Nov 1990
ROADRUNNER WIRE GUIDE
K901899 · Cook, Inc. · Sep 1990
.018 HI-TORQUE FLOPPY GUIDE WIRE W/ PRESHAPED TIP
K902755 · Advanced Cardiovascular Systems, Inc. · Sep 1990