CARDIAC COOLING JACKET, 8 CM, MODEL CJ-420— 510(k) K896971

Substantially Equivalent

Daily Medical Products, Inc.

FDA 510(k) clearance K896971 for CARDIAC COOLING JACKET, 8 CM, MODEL CJ-420, Substantially Equivalent on 1990-02-05. Applicant: Daily Medical Products, Inc..

Clearance details

Applicant: Daily Medical Products, Inc.
Product code: Code DWC
Advisory panel: Cardiovascular
Date received: 1989-12-13
Decision date: 1990-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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Adverse events under product code DWC

product code DWC

Death: 124
Injury: 233
Malfunction: 3,727
Total: 4,084

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.