Cleared Traditional

K002206 - HI-TORQUE WHISPER LS GUIDE WIRE WITH HY...

K002206 is the FDA 510(k) clearance for HI-TORQUE WHISPER LS GUIDE WIRE WITH HY... by Guidant Corp.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K002206 · Guidant Corp. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Aug 2000
Decision
34d
Days
Class 2
Risk

K002206 is an FDA 510(k) clearance for the HI-TORQUE WHISPER LS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE.... Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Guidant Corp. (Santa Clara, US). The FDA issued a Cleared decision on August 24, 2000 after a review of 34 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 Guidant Corp. devices

Submission Details

510(k) Number K002206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2000
Decision Date August 24, 2000
Days to Decision 34 days
Submission Type Traditional
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
91d faster than avg
Panel avg: 125d · This submission: 34d
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 501
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K002206.
MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES
K010511 · Cordis Neurovascular, Inc. · Mar 2001
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K003483 · Lake Region Mfg., Inc. · Dec 2000
INQWIRE DIAGNOSTIC GUIDE WIRE
K002289 · Merit Medical Systems, Inc. · Oct 2000
MIRAGE HYDROPHILIC GUIDEWIRE, MODEL 103-0608
K002212 · Micro Therapeutics, Inc. · Aug 2000
GALEO HYDRO AND GALEO HYDRO J-TIP
K001736 · Biotronik, Inc. · Aug 2000
SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 DIAMETER, 145CM LENGTH, SUPPORT) SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 D
K001454 · Micro Therapeutics, Inc. · Jun 2000