Cleared Traditional

ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter (K171933) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence.

K171933 · Asahi Intecc Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2018
Decision
229d
Days
Class 2
Risk

K171933 is an FDA 510(k) clearance for the ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microc.... Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Asahi Intecc Co., Ltd. (Hagoya-Shi, JP). The FDA issued a Cleared decision on February 12, 2018 after a review of 229 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Asahi Intecc Co., Ltd. devices

Submission Details

510(k) Number K171933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2017
Decision Date February 12, 2018
Days to Decision 229 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
104d slower than avg
Panel avg: 125d · This submission: 229d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

CardioMed Device Consultants, LLC
Candace Cederman

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT02379923 Completed Interventional Industry-sponsored

The Asahi Intecc PTCA Chronic Total Occlusion Study

163
Patients (actual)
12
Sites
Treatment
Purpose
Open label
Masking
Condition studied Coronary Artery Disease; Coronary Artery Chronic Total Occlusion
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator David Kandzari, MD
Sponsor Asahi Intecc USA Inc (industry)
Started 2015-06-01 → Primary completion 2016-01-01
Primary outcome
Procedure Success
Secondary outcome
Frequency of Successful Recanalization
View full study on ClinicalTrials.gov

Regulatory Peers - DQX Wire, Guide, Catheter

All 342
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K171933.
Double Flexible Tip Wire Guides
K171912 · Cook Incorporated · Mar 2018
Fixed Core Wire Guides
K171764 · Cook Incorporated · Mar 2018
Warrior 14 guidewire
K180128 · Vascular Solutions, Inc. · Feb 2018
Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile
K173235 · Scientia Vascular, LLC · Jan 2018
HI-TORQUE TurnTrac Guide Wire Family
K173795 · Abbott Vascular · Jan 2018
Amplatz Support Wire Guide with Apex Curve
K171445 · Cook Incorporated · Jan 2018