Cleared Traditional

K032590 - MICROPLEX COIL SYSTEM (MCS)

K032590 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 61-day FDA review.

K032590 · MicroVention, Inc. · Neurology device
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Oct 2003
Decision
61d
Days
Class 2
Risk

K032590 is an FDA 510(k) clearance for the MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES). 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 22, 2003 after a review of 61 days - a notably fast clearance 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: 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 MicroVention, Inc. devices

Submission Details

510(k) Number K032590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2003
Decision Date October 22, 2003
Days to Decision 61 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
87d faster than avg
Panel avg: 148d · This submission: 61d
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 K032590.
MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D)
K040694 · Micro Therapeutics, Inc. · Mar 2004
SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS
K033372 · Micro Therapeutics, Inc. · Jan 2004
HYDROCOIL EMBOLIC SYSTEM (HES)
K033836 · MicroVention, Inc. · Dec 2003
SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT
K032497 · Micro Therapeutics, Inc. · Sep 2003
TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
K032553 · Cordis Neurovascular, Inc. · Sep 2003
CONTOUR SE MICROSPHERES (SYRINGE)
K032707 · Boston Scientific Corp · Sep 2003