PVA PLUS, MAXISTAT PVA, MICROSTAT PVA FOAM EMBOLIZATION PARTICLES— 510(k) K061790

Name: FDA 510(k) clearance K061790
Creator: U.S. Food and Drug Administration
Published: 2006-09-19

Substantially Equivalent

Protein Polymer Technologies, Inc.

FDA 510(k) clearance K061790 for PVA PLUS, MAXISTAT PVA, MICROSTAT PVA FOAM EMBOLIZATION PARTICLES, Substantially Equivalent on 2006-09-19. Applicant: Protein Polymer Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Protein Polymer Technologies, Inc.
Product code: Code KRD
Device class: Class 2
Regulation: 21 CFR 870.3300
Advisory panel: Cardiovascular
Date received: 2006-06-26
Decision date: 2006-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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K053548 — MODIFIED PVA-PLUS FOAM EMBOLIZATION PARTICLES AND MAXISTAT AND MICROSTAT PVA FOAM EMBOLIZATION PARTICLES2006-01-30

Adverse events under product code KRD

product code KRD

Death: 119
Injury: 1,869
Malfunction: 7,015
Other: 1
Total: 9,004

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.