Cleared Special

K062186 - ASAHI PTCA GUIDE WIRE

K062186 is the FDA 510(k) clearance for ASAHI PTCA GUIDE WIRE by Asahi Intecc Co., Ltd.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Special 510(k) pathway after a 101-day FDA review.

K062186 · Asahi Intecc Co., Ltd. · Cardiovascular device
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Nov 2006
Decision
101d
Days
Class 2
Risk

K062186 is an FDA 510(k) clearance for the ASAHI PTCA GUIDE WIRE, FIELDER J, MODEL AGP140000J, AGP140300J. 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 9, 2006 after a review of 101 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.

View all Asahi Intecc Co., Ltd. devices

Submission Details

510(k) Number K062186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2006
Decision Date November 09, 2006
Days to Decision 101 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
24d faster than avg
Panel avg: 125d · This submission: 101d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 498
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K062186.
COOK MICROWIRE WIRE GUIDE
K070410 · Cook, Inc. · Apr 2007
ASAHI PTCA GUIDE WIRE, FIELDER FC
K063819 · Asahi Intecc Co., Ltd. · Jan 2007
RADIFOCUS GLIDEWIRE ADVANTAGE
K063372 · Terumo Medical Corp. · Jan 2007
TREASURE
K061984 · Asahi Intecc Co., Ltd. · Oct 2006
HI-TORQUE WHISPER VIEW GUIDE WIRE
K061453 · Guidant Corp. · Jun 2006
TITAN GUIDEWIRE
K060454 · Lake Region Mfg., Inc. · Mar 2006