BARRICADE EMBOLIZATION COIL SYSTEM— 510(k) K131475

Name: FDA 510(k) clearance K131475
Creator: U.S. Food and Drug Administration
Published: 2013-07-25

Substantially Equivalent

Blockade Medical

FDA 510(k) clearance K131475 for BARRICADE EMBOLIZATION COIL SYSTEM, Substantially Equivalent on 2013-07-25. Applicant: Blockade Medical. Device class: 2.

Clearance details

Applicant: Blockade Medical
Product code: Code HCG
Device class: Class 2
Regulation: 21 CFR 882.5950
Advisory panel: Neurology
Date received: 2013-05-22
Decision date: 2013-07-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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K254221 — Optima Coil System (OptiOne Coil System)2026-01-27
K252694 — Target Detachable Coil2025-12-11

More clearances from Blockade Medical

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K151760 — Barricade Embolization Coil System2015-07-27
K142513 — Barricade Embolization Coil System2014-11-13
K140104 — BARRICADE EMBOLIZATION COIL SYSTEM2014-02-13
K132482 — BARRICADE EMBOLIZATION COIL SYSTEM2013-10-10
K123338 — BARRICADE EMBOLIZATION COIL SYSTEM2013-03-28

Adverse events under product code HCG

product code HCG

Death: 50
Injury: 801
Malfunction: 5,625
Total: 6,476

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.