MODIFIED PVA-PLUS FOAM EMBOLIZATION PARTICLES AND MAXISTAT AND MICROSTAT PVA FOAM EMBOLIZATION PARTICLES— 510(k) K053548

Substantially Equivalent

Protein Polymer Technologies, Inc.

FDA 510(k) clearance K053548 for MODIFIED PVA-PLUS FOAM EMBOLIZATION PARTICLES AND MAXISTAT AND MICROSTAT PVA FOAM EMBOLIZATION PARTICLES, Substantially Equivalent on 2006-01-30. Applicant: Protein Polymer Technologies, Inc..

Clearance details

Applicant: Protein Polymer Technologies, Inc.
Product code: Code HCG
Advisory panel: Neurology
Date received: 2005-12-20
Decision date: 2006-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, 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.