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

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..

Clearance details

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

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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.