Cleared Special

K171613 - ASAHI Neurovasulature Guide Wire: ASAHI...

K171613 is an FDA 510(k) clearance for ASAHI Neurovasulature Guide Wire: ASAHI..., manufactured by Asahi Intecc Co., Ltd.. The device is a Class 2 Neurology device with product code MOF cleared through the Special 510(k) pathway after a 30-day FDA review.

K171613 · Asahi Intecc Co., Ltd. · Neurology device
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Jul 2017
Decision
30d
Days
Class 2
Risk

K171613 is an FDA 510(k) clearance for the ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip. Classified as Guide, Wire, Catheter, Neurovasculature (product code MOF), Class II - Special Controls.

Submitted by Asahi Intecc Co., Ltd. (Hagoya-Shi, JP). The FDA issued a Cleared decision on July 1, 2017 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1330 - the FDA neurology device 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.

View all Asahi Intecc Co., Ltd. devices

FDA 510(k) Submission Details - K171613

510(k) Number K171613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2017
Decision Date July 01, 2017
Days to Decision 30 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 148d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

MOF Device Classification - Class 2, Special Controls

Product Code MOF Guide, Wire, Catheter, Neurovasculature
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 Neurology 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.

Regulatory Peers - MOF Guide, Wire, Catheter, Neurovasculature

All 38
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