Cleared Traditional

K920891 - ROADRUNNER(TM) WIRE GUIDE, MODIFICATION

K920891 is an FDA 510(k) clearance for ROADRUNNER(TM) WIRE GUIDE, manufactured by Cook, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K920891 · Cook, Inc. · Cardiovascular device
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Dec 1992
Decision
301d
Days
Class 2
Risk

K920891 is an FDA 510(k) clearance for the ROADRUNNER(TM) WIRE GUIDE, MODIFICATION. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on December 21, 1992 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Cook, Inc. devices

FDA 510(k) Submission Details - K920891

510(k) Number K920891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1992
Decision Date December 21, 1992
Days to Decision 301 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
176d slower than avg
Panel avg: 125d · This submission: 301d
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 681
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K920891.
CORDIS STEERABLE GUIDEWIRE
K925833 · Cordis Corp. · Feb 1993
HI-TORQUE SPORT-T(TM) GUIDE WIRE
K915554 · Peripheral Systems Group · Feb 1993
CORDIS VIERA GUIDEWIRE
K923696 · Cordis Corp. · Feb 1993
NAVIGUIDE HYDROPHILIC COATED GUIDEWIRE
K922674 · Meadox Medicals, Div. Boston Scientific Corp. · Dec 1992
TAPER GUIDEWIRES
K924987 · Target Therapeutics · Dec 1992
RADIFOCUS(R) (CATHETER) GUIDE WIRE
K924202 · Terumo Medical Corp. · Nov 1992