Cleared Traditional

K020434 - MICROPLEX COIL SYSTEM (MCS)

K020434 is the FDA 510(k) clearance for MICROPLEX COIL SYSTEM (MCS) by MicroVention, Inc.. It is a Class 2 Neurology device (product code HCG) cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K020434 · MicroVention, Inc. · Neurology device
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Jul 2002
Decision
171d
Days
Class 2
Risk

K020434 is an FDA 510(k) clearance for the MICROPLEX COIL SYSTEM (MCS). 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 July 29, 2002 after a review of 171 days - an extended review cycle.

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 K020434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2002
Decision Date July 29, 2002
Days to Decision 171 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
23d slower than avg
Panel avg: 148d · This submission: 171d
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 K020434.
TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
K030963 · Cordis Neurovascular, Inc. · Jun 2003
MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) WITH THE HYDROLINK SYRINGE KIT
K022735 · MicroVention, Inc. · Sep 2002
CONTOUR SE MICROSPHERES
K022427 · Boston Scientific Corp · Aug 2002
MICROPLEX COIL SYSTEMS (MCS)
K021914 · MicroVention, Inc. · Jul 2002
MICROPLEX COIL SYSTEM
K012145 · MicroVention, Inc. · Oct 2001
DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM
K000651 · Cook, Inc. · Nov 2000