Cleared Special

K032183 - IQ HYDROPHILIC GUIDE WIRE

K032183 is an FDA 510(k) clearance for IQ HYDROPHILIC GUIDE WIRE, manufactured by Boston Scientific Corp. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Special 510(k) pathway after a 15-day FDA review.

K032183 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
15d
Days
Class 2
Risk

K032183 is an FDA 510(k) clearance for the IQ HYDROPHILIC GUIDE WIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on August 1, 2003 after a review of 15 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 - K032183

510(k) Number K032183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2003
Decision Date August 01, 2003
Days to Decision 15 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
110d faster than avg
Panel avg: 125d · This submission: 15d
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 K032183.
PBN GUIDEWIRES
K031442 · Medical Device Technologies, Inc. · Aug 2003
PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES
K032146 · Precision Vascular Systems, Inc. · Aug 2003
PERIVAC KIT
K032050 · Boston Scientific Corp · Aug 2003
GALT MEDICAL GUIDEWIRE
K031916 · Galt Medical Corp. · Jul 2003
RADIUS 018 COUGAR WIRE
K032129 · Radius Medical Technologies, Inc. · Jul 2003
NITREX NITINOL GUIDEWIRE
K031864 · Ev3 Corporation · Jun 2003
K032183 · IQ HYDROPHILIC GUIDE WIRE
Download PDF FDA Summary Boston Scientific Corp