TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION— 510(k) K053197

Substantially Equivalent

Cordis Neurovascular, Inc.

FDA 510(k) clearance K053197 for TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION, Substantially Equivalent on 2005-12-15. Applicant: Cordis Neurovascular, Inc..

Clearance details

Applicant: Cordis Neurovascular, Inc.
Product code: Code HCG
Advisory panel: Neurology
Date received: 2005-11-16
Decision date: 2005-12-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Miami Lake, FL, 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.