Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device— 510(k) K190623

Substantially Equivalent

Medtronic

FDA 510(k) clearance K190623 for Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device, Substantially Equivalent on 2019-05-30. Applicant: Medtronic.

Clearance details

Applicant: Medtronic
Product code: Code OCL
Advisory panel: General, Plastic Surgery
Date received: 2019-03-11
Decision date: 2019-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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.