Cleared Special

K023300 - HI-TORQUE WHISPER LS

Also marketed or referenced as:
HI-TORQUE WHISPER MS HI-TORQUE WHISPER MS CS-J HI-TORQUE WHISPER ES HI-TORQUE WHISPER ES CS-J

K023300 is the FDA 510(k) clearance for HI-TORQUE WHISPER LS by Guidant Corp.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Special 510(k) pathway after a 25-day FDA review.

K023300 · Guidant Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
25d
Days
Class 2
Risk

K023300 is an FDA 510(k) clearance for the HI-TORQUE WHISPER LS. 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 October 28, 2002 after a review of 25 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.

View all Guidant Corp. devices

Submission Details

510(k) Number K023300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2002
Decision Date October 28, 2002
Days to Decision 25 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
100d faster than avg
Panel avg: 125d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 501
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K023300.
PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE
K030617 · Boston Scientific Scimed, Inc. · May 2003
STEERABLE GUIDEWIRE
K022813 · Lake Region Mfg., Inc. · Feb 2003
MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE
K030019 · Guidant Corp. · Jan 2003
SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117
K020821 · Biotronik, Inc. · Jun 2002
HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK AND THE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE
K021228 · Guidant Corp. · May 2002
HI-TORQUE EXTRA S'PORT GUIDEWIRE
K021285 · Guidant Corp. · May 2002