CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES— 510(k) K121878

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K121878 for CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES, Substantially Equivalent on 2012-11-02. Applicant: Medtronic, Inc..

Clearance details

Applicant: Medtronic, Inc.
Product code: Code OCL
Advisory panel: General, Plastic Surgery
Date received: 2012-06-28
Decision date: 2012-11-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Mounds View, 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.