Cleared Special

K131948 - MICROPLEX COIL SYSTEM (MCS)

K131948 is an FDA 510(k) clearance for MICROPLEX COIL SYSTEM (MCS), manufactured by MicroVention, Inc.. The device is a Class 2 Neurology device with product code HCG cleared through the Special 510(k) pathway after a 99-day FDA review.

K131948 · MicroVention, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
99d
Days
Class 2
Risk

K131948 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. (Tistin, US). The FDA issued a Cleared decision on October 4, 2013 after a review of 99 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K131948

510(k) Number K131948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2013
Decision Date October 04, 2013
Days to Decision 99 days
Submission Type Special
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
50d faster than avg
Panel avg: 149d · This submission: 99d
Pathway characteristics
Modification to existing cleared device.

HCG Device Classification - Class 2, Special Controls

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 186
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K131948.
AXIUM DETACHABLE COIL SYSTEM
K133310 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Jan 2014
MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)
K132952 · MicroVention, Inc. · Dec 2013
BARRICADE EMBOLIZATION COIL SYSTEM
K132482 · Blockade Medical · Oct 2013
MICROPLEX COIL SYSTEM (MCS), VFC
K132317 · MicroVention, Inc. · Sep 2013
BARRICADE EMBOLIZATION COIL SYSTEM
K131475 · Blockade Medical · Jul 2013
BARRICADE EMBOLIZATION COIL SYSTEM
K123338 · Blockade Medical · Mar 2013
K131948 · MICROPLEX COIL SYSTEM (MCS)
Download PDF FDA Summary MicroVention, Inc.