CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C; CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 60880— 510(k) K013392

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K013392 for CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C; CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 60880, Substantially Equivalent on 2002-01-25. Applicant: Medtronic Vascular.

Clearance details

Applicant: Medtronic Vascular
Product code: Code OCL
Advisory panel: General, Plastic Surgery
Date received: 2001-10-15
Decision date: 2002-01-25
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Shoreview, 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.