K191526

Substantially Equivalent

Cardioblate CryoFlex Surgical Ablation System

Applicant: Medtronic, Inc.
Product code: OCL
Advisory panel: General, Plastic Surgery
Date received: 2019-06-10
Decision date: 2019-10-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Minneapolis, 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.