Cleared Special

K101985 - ASAHI GUIDE WIRE EXTENSION 165CM

K101985 is an FDA 510(k) clearance for ASAHI GUIDE WIRE EXTENSION 165CM, 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 236-day FDA review.

K101985 · Asahi Intecc Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
236d
Days
Class 2
Risk

K101985 is an FDA 510(k) clearance for the ASAHI GUIDE WIRE EXTENSION 165CM. 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 March 7, 2011 after a review of 236 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 - K101985

510(k) Number K101985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2010
Decision Date March 07, 2011
Days to Decision 236 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
111d slower than avg
Panel avg: 125d · This submission: 236d
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 K101985.
CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283
K103377 · Brivant, Ltd. · May 2011
ACUITY WHISPER VIEW GUIDE WIRES
K110479 · Boston Scientific Corp · Apr 2011
ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE
K110553 · Asahi Intecc USA, Inc. · Mar 2011
APPROACH PRO ST WIRE GUIDE
K110163 · Cook Incorporated · Feb 2011
ENDOLOGIX GUIDEWIRE
K110241 · Techdevice Corporation · Feb 2011
HI-TORQUE BALANCE MIDDLEWEIGHT ELITE
K103101 · Abbott Vascular-Cardiac Therapies · Feb 2011
K101985 · ASAHI GUIDE WIRE EXTENSION 165CM
Download PDF FDA Summary Asahi Intecc Co., Ltd.