K040165

Substantially Equivalent

REFLEXION CANNULATOR STEERABLE ELECTROPHYSIOLOGY CATHETER WITH LUMEN, MODEL 402805

Applicant: St Jude Medical
Product code: DRA
Advisory panel: Cardiovascular
Date received: 2004-01-26
Decision date: 2004-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

Adverse events under product code DRA

product code DRA

Death: 156
Injury: 3,133
Malfunction: 6,266
Total: 9,555

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.