Gatekeeper Balloon Catheter— 510(k) K192786

Substantially Equivalent

Arch Catheter, LLC

FDA 510(k) clearance K192786 for Gatekeeper Balloon Catheter, Substantially Equivalent on 2020-04-25. Applicant: Arch Catheter, LLC.

Clearance details

Applicant: Arch Catheter, LLC
Product code: Code MJN
Advisory panel: Cardiovascular
Date received: 2019-09-30
Decision date: 2020-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ninety Six, SC, 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.