Cleared Special

K161912 - ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip

K161912 is an FDA 510(k) clearance for ASAHI Neurovascular Guide Wire: ASAHI C..., 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 94-day FDA review.

K161912 · Asahi Intecc Co., Ltd. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2016
Decision
94d
Days
Class 2
Risk

K161912 is an FDA 510(k) clearance for the ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 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 October 14, 2016 after a review of 94 days - within the typical 510(k) review window.

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. 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.

FDA 510(k) Submission Details - K161912

510(k) Number K161912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2016
Decision Date October 14, 2016
Days to Decision 94 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
55d faster than avg
Panel avg: 149d · This submission: 94d
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 44
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