Cleared Special

K032615 - ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300

K032615 is an FDA 510(k) clearance for ASAHI PTCA CATHETER GUIDE WIRES, 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 22-day FDA review.

K032615 · Asahi Intecc Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
22d
Days
Class 2
Risk

K032615 is an FDA 510(k) clearance for the ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300. 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 September 16, 2003 after a review of 22 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 - K032615

510(k) Number K032615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2003
Decision Date September 16, 2003
Days to Decision 22 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
103d faster than avg
Panel avg: 125d · This submission: 22d
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 K032615.
RADIUS COUGAR WIRE
K032899 · Radius Medical Technologies, Inc. · Oct 2003
JS VASCULAR GUIDE WIRE VISE/TORQUE DEVICE
K032411 · Js Vascular, Inc. · Oct 2003
VASCUPUNCTURE PICC GUIDEWIRE
K031652 · Neometrics, Inc. · 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
PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES
K032146 · Precision Vascular Systems, Inc. · Aug 2003
K032615 · ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300
Download PDF FDA Summary Asahi Intecc Co., Ltd.