510(k) K960832— OCCLUSION BALLOON CATHETER

Substantially Equivalent

Interventional Therapeutics Corp.

Clearance details

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

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.