Cleared Traditional

K924009 - INTRAVASCULAR GUIDE WIRE AND EXTENSION WIRE

K924009 is an FDA 510(k) clearance for INTRAVASCULAR GUIDE WIRE AND EXTENSION WIRE, manufactured by Pilot Cardiovascular Systems, Inc., Sub. C.R. Bard. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K924009 · Pilot Cardiovascular Systems, Inc., Sub. C.R. Bard · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1992
Decision
88d
Days
Class 2
Risk

K924009 is an FDA 510(k) clearance for the INTRAVASCULAR GUIDE WIRE AND EXTENSION WIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Pilot Cardiovascular Systems, Inc., Sub. C.R. Bard (San Clemente, US). The FDA issued a Cleared decision on November 6, 1992 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pilot Cardiovascular Systems, Inc., Sub. C.R. Bard devices

FDA 510(k) Submission Details - K924009

510(k) Number K924009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1992
Decision Date November 06, 1992
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 125d · This submission: 88d
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 709
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K924009.
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K924202 · Terumo Medical Corp. · Nov 1992
SEEKER LITE - 10
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ROADRUNNER RLTF GUIDE WIRE
K920824 · Cook, Inc. · Oct 1992
BAXTER SENSOR CORONARY GUIDEWIRE
K923240 · Baxter Healthcare Corp · Sep 1992