NEXUS DETACHABLE COIL SYSTEM, HELIX SUPER SOFT CSR— 510(k) K051425

Name: FDA 510(k) clearance K051425
Creator: U.S. Food and Drug Administration
Published: 2005-06-22

Substantially Equivalent

Micro Therapeutics, Inc.

FDA 510(k) clearance K051425 for NEXUS DETACHABLE COIL SYSTEM, HELIX SUPER SOFT CSR, Substantially Equivalent on 2005-06-22. Applicant: Micro Therapeutics, Inc.. Device class: 2.

Clearance details

Applicant: Micro Therapeutics, Inc.
Product code: Code HCG
Device class: Class 2
Regulation: 21 CFR 882.5950
Advisory panel: Neurology
Date received: 2005-06-01
Decision date: 2005-06-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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K090046 — CONCERTO DETACHABLE COIL SYSTEM2009-02-27
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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.