Cleared Special

K043422 - ASAHI PTCA GUIDE WIRE, J SHAPE SERIES

K043422 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 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

FDA 510(k) Submission Details - K043422

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.

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 681
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K043422.
MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE
K043398 · Neometrics, Inc. · Mar 2005
MODIFICATION TO ENDOVASCULAR GUIDE WIRE
K043457 · Stereotaxis, Inc. · Feb 2005
STEREOTAXIS ENDOVASCULAR GUIDE WIRE
K042854 · Stereotaxis, Inc. · Feb 2005
CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE
K040592 · Cordis Corp. · Dec 2004
TORAYGUIDE GUIDEWIRE
K042370 · Toray Industries (America), Inc. · Dec 2004
GUIDEWIRES
K042264 · Rocket Medical Plc · Nov 2004