TRUEFILL PVA PARTICLES— 510(k) K951314

Substantially Equivalent

Cordis Neurovascular, Inc.

FDA 510(k) clearance K951314 for TRUEFILL PVA PARTICLES, Substantially Equivalent on 1995-08-08. Applicant: Cordis Neurovascular, Inc..

Clearance details

Applicant: Cordis Neurovascular, Inc.
Product code: Code HCG
Advisory panel: Neurology
Date received: 1995-03-23
Decision date: 1995-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami Lakes, 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.