K070288

Substantially Equivalent

CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL, 60814

Applicant: Medtronic Vascular
Product code: OCL
Advisory panel: General, Plastic Surgery
Date received: 2007-01-30
Decision date: 2007-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brooklyn Park, MN, US

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.