CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AND 49261— 510(k) K070311

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K070311 for CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AND 49261, Substantially Equivalent on 2007-04-24. Applicant: Medtronic Vascular.

Clearance details

Applicant: Medtronic Vascular
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2007-02-01
Decision date: 2007-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brooklyn Park, MN, US

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Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.