MICRUS MICROCOIL SYSTEM, CASHMERE MODEL SRC— 510(k) K063653

Substantially Equivalent

Micrus Endovascular Corporation

FDA 510(k) clearance K063653 for MICRUS MICROCOIL SYSTEM, CASHMERE MODEL SRC, Substantially Equivalent on 2007-01-17. Applicant: Micrus Endovascular Corporation.

Clearance details

Applicant: Micrus Endovascular Corporation
Product code: Code HCG
Advisory panel: Neurology
Date received: 2006-12-08
Decision date: 2007-01-17
Decision: Substantially Equivalent
Clearance type: Special
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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.