FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC CRYOABLATION CRYOCONSOLE— 510(k) K030303

Substantially Equivalent

Cryocath Technologies, Inc.

FDA 510(k) clearance K030303 for FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC CRYOABLATION CRYOCONSOLE, Substantially Equivalent on 2003-04-29. Applicant: Cryocath Technologies, Inc..

Clearance details

Applicant: Cryocath Technologies, Inc.
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 2003-01-29
Decision date: 2003-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kirkland, CA

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Adverse events under product code GEH

product code GEH

Death: 25
Injury: 351
Malfunction: 901
Total: 1,277

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.