Cleared Special

K032899 - RADIUS COUGAR WIRE

K032899 is an FDA 510(k) clearance for RADIUS COUGAR WIRE, manufactured by Radius Medical Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Special 510(k) pathway after a 30-day FDA review.

K032899 · Radius Medical Technologies, Inc. · Cardiovascular device
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Oct 2003
Decision
30d
Days
Class 2
Risk

K032899 is an FDA 510(k) clearance for the RADIUS COUGAR WIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Radius Medical Technologies, Inc. (Hopkonton, US). The FDA issued a Cleared decision on October 17, 2003 after a review of 30 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 Radius Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K032899

510(k) Number K032899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2003
Decision Date October 17, 2003
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
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 522
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K032899.
IQ GUIDE WIRE
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ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300
K032615 · Asahi Intecc Co., Ltd. · Sep 2003
HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K031678 · Guidant Corp. · Aug 2003
PBN GUIDEWIRES
K031442 · Medical Device Technologies, Inc. · Aug 2003