Cleared Traditional

K123338 - BARRICADE EMBOLIZATION COIL SYSTEM

K123338 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 Traditional 510(k) pathway after a 148-day FDA review.

K123338 · Blockade Medical · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
148d
Days
Class 2
Risk

K123338 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 March 28, 2013 after a review of 148 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 Blockade Medical devices

FDA 510(k) Submission Details - K123338

510(k) Number K123338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2012
Decision Date March 28, 2013
Days to Decision 148 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 148d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K123338.
MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)
K132952 · MicroVention, Inc. · Dec 2013
MICROPLEX COIL SYSTEM (MCS)
K131948 · MicroVention, Inc. · Oct 2013
MICROPLEX COIL SYSTEM (MCS), VFC
K132317 · MicroVention, Inc. · Sep 2013
VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM
K123560 · Codman & Shurtleff, Inc. · Jan 2013
TARGET DETACHABLE COIL
K123377 · Stryker Neurovascular · Nov 2012
HYDROCOIL EMBOLIC SYSTEM (HES)
K120908 · MicroVention, Inc. · Apr 2012