REFLEXION CANNULATOR STEERABLE ELECTROPHYSIOLOGY CATHETER WITH LUMEN, MODEL 402805— 510(k) K040165

Substantially Equivalent

St Jude Medical

FDA 510(k) clearance K040165 for REFLEXION CANNULATOR STEERABLE ELECTROPHYSIOLOGY CATHETER WITH LUMEN, MODEL 402805, Substantially Equivalent on 2004-05-12. Applicant: St Jude Medical.

Clearance details

Applicant: St Jude Medical
Product code: 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

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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.