Cleared Traditional

K901899 - ROADRUNNER WIRE GUIDE

K901899 is the FDA 510(k) clearance for ROADRUNNER WIRE GUIDE by Cook, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K901899 · Cook, Inc. · Cardiovascular device
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Sep 1990
Decision
153d
Days
Class 2
Risk

K901899 is an FDA 510(k) clearance for the ROADRUNNER WIRE GUIDE. 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 September 27, 1990 after a review of 153 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 Cook, Inc. devices

Submission Details

510(k) Number K901899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1990
Decision Date September 27, 1990
Days to Decision 153 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
28d slower than avg
Panel avg: 125d · This submission: 153d
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 K901899.
GUIDEWIRE
K904477 · Datascope Corp. · Dec 1990
CORDIS CINCH(TM) STEER GUIDEWIRE EXTEN W/SLX COAT
K902612 · Cordis Corp. · Dec 1990
USCI(R) SILK (TM) GUIDE WIRE
K903923 · C.R. Bard, Inc. · Nov 1990
.018 HI-TORQUE FLOPPY GUIDE WIRE W/ PRESHAPED TIP
K902755 · Advanced Cardiovascular Systems, Inc. · Sep 1990
ACS .010 HI-TORQUE INTER. AND STANDARD GUIDE WIRE
K902207 · Advanced Cardiovascular Systems, Inc. · Aug 1990
DATASCOPE SLIDEWIRE(TM)
K901347 · Datascope Corp. · Jun 1990