DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM)— 510(k) K032041

Substantially Equivalent

LeMaitre Vascular, Inc.

FDA 510(k) clearance K032041 for DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM), Substantially Equivalent on 2003-08-27. Applicant: LeMaitre Vascular, Inc..

Clearance details

Applicant: LeMaitre Vascular, Inc.
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 2003-07-01
Decision date: 2003-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DWF

product code DWF

Death: 106
Injury: 386
Malfunction: 2,323
Total: 2,815

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.