BLOOD WARMER (CODE 4R4305)— 510(k) K760012

Substantially Equivalent

Travenol Laboratories, S.A.

FDA 510(k) clearance K760012 for BLOOD WARMER (CODE 4R4305), Substantially Equivalent on 1976-07-16. Applicant: Travenol Laboratories, S.A..

Clearance details

Applicant: Travenol Laboratories, S.A.
Product code: Code BSB
Advisory panel: Hematology
Date received: 1976-06-10
Decision date: 1976-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code BSB

product code BSB

Death: 5
Malfunction: 1,778
Total: 1,783

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.