K974320

Substantially Equivalent

CRYOGEN CARDIAC CRYOSURGICAL SYSTEM

Applicant: Cryogen, Inc.
Product code: OCL
Advisory panel: General, Plastic Surgery
Date received: 1997-11-17
Decision date: 1998-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, 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.