M-BOLUS EMBOLIC MICROSPHERES— 510(k) K052509

Name: FDA 510(k) clearance K052509
Creator: U.S. Food and Drug Administration
Published: 2006-12-11

Substantially Equivalent

Scion Cardio-Vascular, Inc.

FDA 510(k) clearance K052509 for M-BOLUS EMBOLIC MICROSPHERES, Substantially Equivalent on 2006-12-11. Applicant: Scion Cardio-Vascular, Inc.. Device class: 2.

Clearance details

Applicant: Scion Cardio-Vascular, Inc.
Product code: Code HCG
Device class: Class 2
Regulation: 21 CFR 882.5950
Advisory panel: Neurology
Date received: 2005-09-13
Decision date: 2006-12-11
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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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.