Cleared Traditional

K111451 - MICROPLEX COIL SYSTEM-VECTOR MODEL 0306...

K111451 is the FDA 510(k) clearance for MICROPLEX COIL SYSTEM-VECTOR MODEL 0306... by MicroVention, Inc.. It is a Class 2 Neurology device (product code HCG) cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K111451 · MicroVention, Inc. · Neurology device
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Sep 2011
Decision
118d
Days
Class 2
Risk

K111451 is an FDA 510(k) clearance for the MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 0610.... Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by MicroVention, Inc. (Tistin, US). The FDA issued a Cleared decision on September 20, 2011 after a review of 118 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 K111451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2011
Decision Date September 20, 2011
Days to Decision 118 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
30d faster than avg
Panel avg: 148d · This submission: 118d
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 104
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K111451.
HYDROCOIL EMBOLIC SYSTEM (HES)
K113457 · MicroVention, Inc. · Dec 2011
HYDROCOIL(R) EMBOLIC SYSTEM (HES)
K112181 · MicroVention, Inc. · Dec 2011
HYDROCOIL EMBOLIC SYSTEM (HES)
K112226 · MicroVention, Inc. · Sep 2011
MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10
K103758 · MicroVention, Inc. · Apr 2011
GDC 360 DETEACHABLE COIL
K103355 · Boston Scientific Corp · Feb 2011
PENUMBRA EMBOLIZATION COIL SYSTEM
K103305 · Penumbra, Inc. · Jan 2011