Cleared Traditional

K113716 - ASAHI CHIKAI V PERIPHERAL VASCULAR GUID...

K113716 is the FDA 510(k) clearance for ASAHI CHIKAI V PERIPHERAL VASCULAR GUID... by Asahi Intecc Co., Ltd.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K113716 · Asahi Intecc Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
49d
Days
Class 2
Risk

K113716 is an FDA 510(k) clearance for the ASAHI CHIKAI V PERIPHERAL VASCULAR 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 February 6, 2012 after a review of 49 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Asahi Intecc Co., Ltd. devices

Submission Details

510(k) Number K113716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2011
Decision Date February 06, 2012
Days to Decision 49 days
Submission Type Traditional
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
76d faster than avg
Panel avg: 125d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 443
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K113716.
MERIT HYDROPHILIC GUIDE WIRE
K120644 · Merit Medical Systems, Inc. · Sep 2012
AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE
K121776 · Codman & Shurtleff, Inc. · Aug 2012
WHOLEY GUIDE WIRE SYSTEM
K120863 · Covidien, LLC · Apr 2012
VSI GUIDEWIRE
K112631 · Vascular Solutions, Inc. · Oct 2011
V-14 CONTROL WIRE GUIDEWIRE
K112745 · Boston Scientific Corporation · Oct 2011
ASAHI ULTIMATEBROS 3 PTCA GUIDE WIRE
K101986 · Asahi Intecc Co., Ltd. · Sep 2011