Cleared Special

K072705 - ASAHI PTCA GUIDE WIRE

K072705 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 29-day FDA review.

K072705 · Asahi Intecc Co., Ltd. · Cardiovascular device
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Oct 2007
Decision
29d
Days
Class 2
Risk

K072705 is an FDA 510(k) clearance for the ASAHI PTCA GUIDE WIRE, FIELDER FC J, MODELS: AGP140001J, AGP140301J. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Asahi Intecc Co., Ltd. (Santa Ana, US). The FDA issued a Cleared decision on October 23, 2007 after a review of 29 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 K072705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2007
Decision Date October 23, 2007
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
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 K072705.
PEGASUS STEERABLE (PTCA) GUIDEWIRE
K073655 · Lake Region Mfg., Inc. · Jan 2008
ASAHI PTCA GUIDE WIRE
K070945 · Asahi Intecc Co., Ltd. · Jan 2008
MERIT MEDICAL SYSTEMS, INC., GUIDE WIRE TORQUE DEVICE
K072552 · Merit Medical Systems, Inc. · Dec 2007
ASAHI PTCA GUIDE WIRE, X-TREME
K072431 · Asahi Intecc Co., Ltd. · Sep 2007
ASAHI ASTATO 30 PERIPHERAL GUIDE WIRE, MODELS - PAGH18M071, PAGH18M371
K071721 · Asahi Intecc Co., Ltd. · Jul 2007
RUNTHROUGH NS
K063695 · Terumo Medical Corp. · Apr 2007