OCCLUSION BALLOON CATHETER— 510(k) K132990

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K132990 for OCCLUSION BALLOON CATHETER, Substantially Equivalent on 2013-10-22. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code MJN
Advisory panel: Cardiovascular
Date received: 2013-09-24
Decision date: 2013-10-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Maple Grove, MN, US

Download summary PDF View on FDA.gov ↗

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.