Cleared Special

K052339 - ASAHI PTCA GUIDE WIRE

K052339 is an FDA 510(k) clearance for ASAHI PTCA GUIDE WIRE, manufactured by Asahi Intecc Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Special 510(k) pathway after a 96-day FDA review.

K052339 · Asahi Intecc Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
96d
Days
Class 2
Risk

K052339 is an FDA 510(k) clearance for the ASAHI PTCA GUIDE WIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Asahi Intecc Co., Ltd. (Newport Beach, US). The FDA issued a Cleared decision on November 30, 2005 after a review of 96 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K052339

510(k) Number K052339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2005
Decision Date November 30, 2005
Days to Decision 96 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
29d faster than avg
Panel avg: 125d · This submission: 96d
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 K052339.
PVS 2000 SYNCHRO2 GUIDEWIRE
K053268 · Boston Scientific - Precision Vascular · Mar 2006
TECHDEVICE GUIDEWIRE
K053251 · Techdevice Corporation · Mar 2006
TITAN STEERABLE (PTCA) GUIDEWIRE
K052347 · Lake Region Mfg., Inc. · Feb 2006
MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX
K052783 · Boston Scientific Corp · Oct 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
K052339 · ASAHI PTCA GUIDE WIRE
Download PDF FDA Summary Asahi Intecc Co., Ltd.