CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205— 510(k) K090721

Substantially Equivalent

Medtronic

FDA 510(k) clearance K090721 for CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205, Substantially Equivalent on 2009-06-16. Applicant: Medtronic.

Clearance details

Applicant: Medtronic
Product code: Code OCL
Advisory panel: General, Plastic Surgery
Date received: 2009-03-18
Decision date: 2009-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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Adverse events under product code OCL

product code OCL

Death: 34
Injury: 256
Total: 290

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.