OCCLUSION BALLOON CATHETER— 510(k) K960832

Name: FDA 510(k) clearance K960832
Creator: U.S. Food and Drug Administration
Published: 1996-05-29

Substantially Equivalent

Interventional Therapeutics Corp.

FDA 510(k) clearance K960832 for OCCLUSION BALLOON CATHETER, Substantially Equivalent on 1996-05-29. Applicant: Interventional Therapeutics Corp.. Device class: 2.

Clearance details

Applicant: Interventional Therapeutics Corp.
Product code: Code MJN
Device class: Class 2
Regulation: 21 CFR 870.4450
Advisory panel: Cardiovascular
Date received: 1996-02-29
Decision date: 1996-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MJN

product code MJN

Death: 31
Injury: 240
Malfunction: 827
Total: 1,098

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.