Cleared Special

K052783 - MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX

K052783 is an FDA 510(k) clearance for MODIFICATION TO: IQ 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 24-day FDA review.

K052783 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
24d
Days
Class 2
Risk

K052783 is an FDA 510(k) clearance for the MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX. 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 October 27, 2005 after a review of 24 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 - K052783

510(k) Number K052783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2005
Decision Date October 27, 2005
Days to Decision 24 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
101d faster than avg
Panel avg: 125d · This submission: 24d
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 K052783.
TECHDEVICE GUIDEWIRE
K053251 · Techdevice Corporation · Mar 2006
TITAN STEERABLE (PTCA) GUIDEWIRE
K052347 · Lake Region Mfg., Inc. · Feb 2006
ASAHI PTCA GUIDE WIRE
K052339 · Asahi Intecc Co., Ltd. · Nov 2005
ASAHI PTCA GUIDE WIRE FIELDER
K052022 · Asahi Intecc Co., Ltd. · Aug 2005
VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST
K051062 · Flowcardia, Inc. · Jul 2005
CARDIODRIVE CATHETER ADVANCEMENT SYSTEM
K051374 · Stereotaxis, Inc. · Jun 2005
K052783 · MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX
Download PDF FDA Summary Boston Scientific Corp