Cleared Traditional

K112979 - ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIRE

K112979 is the FDA 510(k) clearance for ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIRE by Asahi Intecc Co., Ltd.. It is a Class 2 Neurology device (product code MOF) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K112979 · Asahi Intecc Co., Ltd. · Neurology device
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Optimized for regulatory review, auditing and printing
Dec 2011
Decision
56d
Days
Class 2
Risk

K112979 is an FDA 510(k) clearance for the ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIRE. Classified as Guide, Wire, Catheter, Neurovasculature (product code MOF), Class II - Special Controls.

Submitted by Asahi Intecc Co., Ltd. (Santa Ana, US). The FDA issued a Cleared decision on December 1, 2011 after a review of 56 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Asahi Intecc Co., Ltd. devices

Submission Details

510(k) Number K112979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2011
Decision Date December 01, 2011
Days to Decision 56 days
Submission Type Traditional
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
92d faster than avg
Panel avg: 148d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - MOF Guide, Wire, Catheter, Neurovasculature

All 38
Devices cleared under the same product code (MOF) and FDA review panel - the closest regulatory comparables to K112979.
ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI BLACK, ASAHI NEUROVASCULAR
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TRAXCESS 14 GUIDEWIRE
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K133625 · Codman & Shurtleff, Inc. · Feb 2014
ASAHI CHIKAI NEUROVASCULAR GUIDE WIRE
K110584 · Asahi Intecc Co., Ltd. · Aug 2011