Cleared Traditional

K191464 - Asahi PTCA Guide Wire Asahi SION Series

K191464 is the FDA 510(k) clearance for Asahi PTCA Guide Wire Asahi SION Series by Asahi Intecc Co., Ltd.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K191464 · Asahi Intecc Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2019
Decision
171d
Days
Class 2
Risk

K191464 is an FDA 510(k) clearance for the Asahi PTCA Guide Wire Asahi SION Series. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Asahi Intecc Co., Ltd. (Seto, JP). The FDA issued a Cleared decision on November 21, 2019 after a review of 171 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 K191464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2019
Decision Date November 21, 2019
Days to Decision 171 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
46d slower than avg
Panel avg: 125d · This submission: 171d
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 Consultant

Asahi Intecc USA, Inc.
Cynthia Valenzuela

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.

Regulatory Peers - DQX Wire, Guide, Catheter

All 499
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K191464.
CrossTorq 14 Guidewire
K193194 · Scientia Cardio Access, LLC · Dec 2019
HI-TORQUE InfilTrac Guide Wire Family
K193126 · Abbott Vascular · Dec 2019
Heraeus Peripheral Guidewire
K191502 · Heraeus Medical Components, LLC · Nov 2019
Aristotle 24 Guidewire, 200cm, Soft Profile
K192783 · Scientia Vascular, LLC · Oct 2019
pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire
K191687 · Phenox Limited · Oct 2019
MINAMO
K190176 · Asahi Intecc Co., Ltd. · Aug 2019