RADIOPAQUE SPHERICAL EMBOLI (RSE)— 510(k) K871047

Name: FDA 510(k) clearance K871047
Creator: U.S. Food and Drug Administration
Published: 1987-05-22

Substantially Equivalent

Interventional Therapeutics Corp.

FDA 510(k) clearance K871047 for RADIOPAQUE SPHERICAL EMBOLI (RSE), Substantially Equivalent on 1987-05-22. Applicant: Interventional Therapeutics Corp.. Device class: 2.

Clearance details

Applicant: Interventional Therapeutics Corp.
Product code: Code HCG
Device class: Class 2
Regulation: 21 CFR 882.5950
Advisory panel: Neurology
Date received: 1987-03-17
Decision date: 1987-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Barbara, CA, 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.