Cleared Special

K211898 - ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20 (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway.

K211898 · Asahi Intecc Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2021
Decision
170d
Days
Class 2
Risk

K211898 is an FDA 510(k) clearance for the ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20. 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 December 8, 2021 after a review of 170 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.

View all Asahi Intecc Co., Ltd. devices

Submission Details

510(k) Number K211898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2021
Decision Date December 08, 2021
Days to Decision 170 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
45d slower than avg
Panel avg: 125d · This submission: 170d
Pathway characteristics
Modification to existing cleared device.

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

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.

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 762
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K211898.
FMD Peripheral Guide Wire F-14 Flex 6
K260544 · FMD Co., Ltd. · Mar 2026
Enroute 0.014'' Transcarotid Guidewire
K253746 · Lake Region Medical · Mar 2026
EmeryGlide™ (EG18008901)
K253262 · Nano4imaging GmbH · Mar 2026
Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)
K253847 · Merit Medical Ireland, Ltd. · Jan 2026
InQwire Super Stiff Guide Wire (IQSS32180J3)
K251385 · Merit Medical Ireland, Ltd. · Jan 2026
Solo Pace Fusion System (SOLOFUSE1)
K252674 · Solo Pace, Inc. · Jan 2026