AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304— 510(k) K042623

Substantially Equivalent

St. Jude Medical, Daig Division, Inc.

FDA 510(k) clearance K042623 for AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304, Substantially Equivalent on 2005-01-27. Applicant: St. Jude Medical, Daig Division, Inc..

Clearance details

Applicant: St. Jude Medical, Daig Division, Inc.
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 2004-09-27
Decision date: 2005-01-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Minnetonka, MN, US

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Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

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.