Cleared Special

K140104 - BARRICADE EMBOLIZATION COIL SYSTEM

K140104 is an FDA 510(k) clearance for BARRICADE EMBOLIZATION COIL SYSTEM, manufactured by Blockade Medical. The device is a Class 2 Neurology device with product code HCG cleared through the Special 510(k) pathway after a 29-day FDA review.

K140104 · Blockade Medical · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
29d
Days
Class 2
Risk

K140104 is an FDA 510(k) clearance for the BARRICADE EMBOLIZATION COIL SYSTEM. Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by Blockade Medical (Irvine, US). The FDA issued a Cleared decision on February 13, 2014 after a review of 29 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Blockade Medical devices

FDA 510(k) Submission Details - K140104

510(k) Number K140104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2014
Decision Date February 13, 2014
Days to Decision 29 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 148d · This submission: 29d
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 156
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K140104.
Penumbra Smart Coil
K143218 · Penumbra, Inc. · Mar 2015
CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector Cable
K142429 · Codman & Shurtleff, Inc. · Dec 2014
POD SYSTEM
K141134 · Penumbra, Inc. · Jul 2014
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
MICROPLEX COIL SYSTEM (MCS)
K131948 · MicroVention, Inc. · Oct 2013