CARDIOTOMY RESERVOIR— 510(k) K780517

Substantially Equivalent

Travenol Laboratories, S.A.

FDA 510(k) clearance K780517 for CARDIOTOMY RESERVOIR, Substantially Equivalent on 1978-04-13. Applicant: Travenol Laboratories, S.A..

Clearance details

Applicant: Travenol Laboratories, S.A.
Product code: Code DTN
Advisory panel: Cardiovascular
Date received: 1978-03-31
Decision date: 1978-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTN

product code DTN

Death: 3
Total: 3

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.