Cleared Special

K151760 - Barricade Embolization Coil System

K151760 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 28-day FDA review.

K151760 · Blockade Medical · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
28d
Days
Class 2
Risk

K151760 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 July 27, 2015 after a review of 28 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.

FDA 510(k) Submission Details - K151760

510(k) Number K151760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2015
Decision Date July 27, 2015
Days to Decision 28 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
121d faster than avg
Panel avg: 149d · This submission: 28d
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 185
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K151760.
InZone Detachment System
K160096 · Stryker Neurovascular · Feb 2016
MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)
K153594 · MicroVention, Inc. · Jan 2016
Axium Detachable Coil System
K151447 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Jul 2015
Penumbra Smart Coil
K151572 · Penumbra, Inc. · Jul 2015
MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS
K150319 · Codman & Shurtleff, Inc. · Jun 2015
Penumbra Smart Coil
K143218 · Penumbra, Inc. · Mar 2015
K151760 · Barricade Embolization Coil System
Download PDF FDA Summary Blockade Medical