Cleared Special

K100578 - ASAHI SION PTCA GUIDE WIRE MODEL AHW14R001S & AHW14R301S

K100578 is an FDA 510(k) clearance for ASAHI SION PTCA GUIDE WIRE MODEL AHW14R..., 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 205-day FDA review.

K100578 · Asahi Intecc Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
205d
Days
Class 2
Risk

K100578 is an FDA 510(k) clearance for the ASAHI SION PTCA GUIDE WIRE MODEL AHW14R001S & AHW14R301S. 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 September 22, 2010 after a review of 205 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 - K100578

510(k) Number K100578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2010
Decision Date September 22, 2010
Days to Decision 205 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
80d slower than avg
Panel avg: 125d · This submission: 205d
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 762
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K100578.
ASAHI ASTATO XS 20 PERIPHERAL GUIDE WIRE
K103057 · Asahi Intecc Co., Ltd. · Nov 2010
PERCU-PRO GUIDEWIRE
K094062 · Cardiosolutions, Inc. · Sep 2010
NEOWIRE PTA/PTCA GUIDEWIRE
K101729 · Neometrics, Inc. · Sep 2010
CRUISER 18 GUIDEWIRE
K102211 · Brivant, Ltd. · Sep 2010
ARCHER SUPER STIFF GUIDEWIRES
K101339 · Medtronic, Inc. · Aug 2010
HI-TORQUE WINN GUIDE WIRE FAMILY
K101648 · Abbott Vascular, Inc. · Jul 2010
K100578 · ASAHI SION PTCA GUIDE WIRE MODEL AHW14R001S & AHW14R301S
Download PDF FDA Summary Asahi Intecc Co., Ltd.