K202049

Substantially Equivalent

Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter

Applicant: Applied Medical Resources Corporation
Product code: DXE
Advisory panel: Cardiovascular
Date received: 2020-07-24
Decision date: 2021-09-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Rancho Santa, CA, US

Adverse events under product code DXE

product code DXE

Death: 27
Injury: 258
Malfunction: 2,266
Total: 2,551

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.