Cleared Special

K030019 - MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE

K030019 is an FDA 510(k) clearance for MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE, manufactured by Guidant Corp.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Special 510(k) pathway after a 21-day FDA review.

K030019 · Guidant Corp. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
21d
Days
Class 2
Risk

K030019 is an FDA 510(k) clearance for the MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Guidant Corp. (St Paul, US). The FDA issued a Cleared decision on January 24, 2003 after a review of 21 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K030019

510(k) Number K030019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2003
Decision Date January 24, 2003
Days to Decision 21 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 125d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

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 768
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K030019.
JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002
K031277 · Jomed, Inc. · May 2003
STEERABLE GUIDEWIRE
K022813 · Lake Region Mfg., Inc. · Feb 2003
NITREX NITINOL GUIDEWIRE
K024021 · Ev3 Corporation · Jan 2003
JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050
K022762 · Jomed, Inc. · Dec 2002
PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE
K023700 · Precision Vascular Systems, Inc. · Dec 2002
ENDOVASCULAR GUIDE WIRE
K021363 · Stereotaxis, Inc. · Nov 2002
K030019 · MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE
Download PDF FDA Summary Guidant Corp.