Cleared Special

K110553 - ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE

K110553 is an FDA 510(k) clearance for ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE, manufactured by Asahi Intecc USA, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Special 510(k) pathway after a 18-day FDA review.

K110553 · Asahi Intecc USA, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
18d
Days
Class 2
Risk

K110553 is an FDA 510(k) clearance for the ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Asahi Intecc USA, Inc. (Santa Ana, US). The FDA issued a Cleared decision on March 18, 2011 after a review of 18 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.

FDA 510(k) Submission Details - K110553

510(k) Number K110553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2011
Decision Date March 18, 2011
Days to Decision 18 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
107d faster than avg
Panel avg: 125d · This submission: 18d
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 K110553.
FATHOM (TM) 14 STEERABLE GUIDEWIRE
K111498 · Boston Scientific Corp · Jun 2011
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 GUIDE WIRE EXTENSION 165CM
K101985 · Asahi Intecc Co., Ltd. · Mar 2011
APPROACH PRO ST WIRE GUIDE
K110163 · Cook Incorporated · Feb 2011
ENDOLOGIX GUIDEWIRE
K110241 · Techdevice Corporation · Feb 2011
K110553 · ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE
Download PDF FDA Summary Asahi Intecc USA, Inc.