TRUFILL DCS DETACHABLE COIL AND FRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS DETACHABLE COIL SYSTEM— 510(k) K014041

Substantially Equivalent

Cordis Neurovascular

FDA 510(k) clearance K014041 for TRUFILL DCS DETACHABLE COIL AND FRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS DETACHABLE COIL SYSTEM, Substantially Equivalent on 2002-03-07. Applicant: Cordis Neurovascular.

Clearance details

Applicant: Cordis Neurovascular
Product code: Code HCG
Advisory panel: Neurology
Date received: 2001-12-07
Decision date: 2002-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
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.