K992940

Substantially Equivalent

LEMAITRE BALLOON CATHETER WITH IRRIGATION

Applicant: Vascutech, Inc.
Product code: DXE
Advisory panel: Cardiovascular
Date received: 1999-08-31
Decision date: 2000-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, MA, 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.