Cleared Special

K043422 - ASAHI PTCA GUIDE WIRE

K043422 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 30-day FDA review.

K043422 · Asahi Intecc Co., Ltd. · Cardiovascular device
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Jan 2005
Decision
30d
Days
Class 2
Risk

K043422 is an FDA 510(k) clearance for the ASAHI PTCA GUIDE WIRE, J SHAPE SERIES. 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 January 12, 2005 after a review of 30 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.

View all Asahi Intecc Co., Ltd. devices

Submission Details

510(k) Number K043422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2004
Decision Date January 12, 2005
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
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 K043422.
ASAHI PTCA GUIDE WIRE FIELDER
K052022 · Asahi Intecc Co., Ltd. · Aug 2005
CANALIZER HYDROPHILIC GUIDE WIRE
K050873 · Medical Device Technologies, Inc. · May 2005
GALEO FOCUS GUIDE WIRE
K042373 · Biotronik, Inc. · Mar 2005
CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE
K040592 · Cordis Corp. · Dec 2004
LUNDERQUIST EXTRA STIFF DOUBLE CURVED EXCHANGE WIRE GUIDE
K042611 · Cook, Inc. · Nov 2004
CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE
K042338 · Lake Region Mfg., Inc. · Sep 2004