Cleared Traditional

K920891 - ROADRUNNER(TM) WIRE GUIDE

K920891 is the FDA 510(k) clearance for ROADRUNNER(TM) WIRE GUIDE by Cook, Inc.. It is a Class 2 Cardiovascular device (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

Submission Details

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.

Device Classification

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 500
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K920891.
ACS HI-TORQUE BALANCE(TM) GUIDE WIRE
K925381 · Advanced Cardiovascular Systems, Inc. · Feb 1993
CORDIS STEERABLE GUIDEWIRE
K925833 · Cordis Corp. · 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