ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER— 510(k) K121006

Substantially Equivalent

St Jude Medical

FDA 510(k) clearance K121006 for ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER, Substantially Equivalent on 2012-05-03. Applicant: St Jude Medical.

Clearance details

Applicant: St Jude Medical
Product code: Code MTD
Advisory panel: Cardiovascular
Date received: 2012-04-03
Decision date: 2012-05-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Minnetonka, MN, US

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Adverse events under product code MTD

product code MTD

Death: 22
Injury: 376
Malfunction: 986
Total: 1,384

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.