REBOA Balloon Catheter— 510(k) K160598

Substantially Equivalent

NuMED, Inc.

FDA 510(k) clearance K160598 for REBOA Balloon Catheter, Substantially Equivalent on 2016-06-20. Applicant: NuMED, Inc..

Clearance details

Applicant: NuMED, Inc.
Product code: Code MJN
Advisory panel: Cardiovascular
Date received: 2016-03-02
Decision date: 2016-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hopkinton, NY, 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.