Cleared Traditional

K012145 - MICROPLEX COIL SYSTEM

K012145 is the FDA 510(k) clearance for MICROPLEX COIL SYSTEM by MicroVention, Inc.. It is a Class 2 Neurology device (product code HCG) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K012145 · MicroVention, Inc. · Neurology device
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Oct 2001
Decision
111d
Days
Class 2
Risk

K012145 is an FDA 510(k) clearance for the MICROPLEX COIL SYSTEM. Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by MicroVention, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on October 29, 2001 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5950 - 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 MicroVention, Inc. devices

Submission Details

510(k) Number K012145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2001
Decision Date October 29, 2001
Days to Decision 111 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
37d faster than avg
Panel avg: 148d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HCG Device, Neurovascular Embolization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5950
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 - HCG Device, Neurovascular Embolization

All 116
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K012145.
CONTOUR SE MICROSPHERES
K022427 · Boston Scientific Corp · Aug 2002
MICROPLEX COIL SYSTEM (MCS)
K020434 · MicroVention, Inc. · Jul 2002
MICROPLEX COIL SYSTEMS (MCS)
K021914 · MicroVention, Inc. · Jul 2002
DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM
K000651 · Cook, Inc. · Nov 2000
VASCULAR OCCLUSION SYSTEM
K983483 · Cordis Neurovascular, Inc. · Mar 1999
CES VASCULAR OCCLUSION SYSTEM
K972881 · Cordis Neurovascular, Inc. · Jun 1998