Cleared Special

K070945 - ASAHI PTCA GUIDE WIRE

K070945 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 280-day FDA review.

K070945 · Asahi Intecc Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
280d
Days
Class 2
Risk

K070945 is an FDA 510(k) clearance for the ASAHI PTCA GUIDE WIRE. 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 January 9, 2008 after a review of 280 days - an extended review 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. 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.

FDA 510(k) Submission Details - K070945

510(k) Number K070945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2007
Decision Date January 09, 2008
Days to Decision 280 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
155d slower than avg
Panel avg: 125d · This submission: 280d
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 K070945.
MANDREL GUIDEWIRES OR M-WIRES
K080144 · Lake Region Mfg., Inc. · Feb 2008
SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM, SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING
K073162 · Kensey Nash Corporation · Feb 2008
PEGASUS STEERABLE (PTCA) GUIDEWIRE
K073655 · Lake Region Mfg., Inc. · Jan 2008
CPS COURIER GUIDEWIRE
K073082 · Brivant, Ltd. · Jan 2008
MERIT MEDICAL SYSTEMS, INC., GUIDE WIRE TORQUE DEVICE
K072552 · Merit Medical Systems, Inc. · Dec 2007
ASAHI PTCA GUIDE WIRE, FIELDER FC J, MODELS: AGP140001J, AGP140301J
K072705 · Asahi Intecc Co., Ltd. · Oct 2007
K070945 · ASAHI PTCA GUIDE WIRE
Download PDF FDA Summary Asahi Intecc Co., Ltd.