Cleared Traditional

K110584 - ASAHI CHIKAI NEUROVASCULAR GUIDE WIRE

K110584 is an FDA 510(k) clearance for ASAHI CHIKAI NEUROVASCULAR GUIDE WIRE, manufactured by Asahi Intecc Co., Ltd.. The device is a Class 2 Neurology device with product code MOF cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K110584 · Asahi Intecc Co., Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
174d
Days
Class 2
Risk

K110584 is an FDA 510(k) clearance for the ASAHI CHIKAI 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 August 22, 2011 after a review of 174 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Asahi Intecc Co., Ltd. devices

FDA 510(k) Submission Details - K110584

510(k) Number K110584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2011
Decision Date August 22, 2011
Days to Decision 174 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
26d slower than avg
Panel avg: 148d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - MOF Guide, Wire, Catheter, Neurovasculature

All 42
Devices cleared under the same product code (MOF) and FDA review panel - the closest regulatory comparables to K110584.
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