MINIPRIME HYPOTHERMIC HEAT EXCHANGER— 510(k) K791430

Substantially Equivalent

Travenol Laboratories, S.A.

FDA 510(k) clearance K791430 for MINIPRIME HYPOTHERMIC HEAT EXCHANGER, Substantially Equivalent on 1979-08-28. Applicant: Travenol Laboratories, S.A..

Clearance details

Applicant: Travenol Laboratories, S.A.
Product code: Code DTR
Advisory panel: Cardiovascular
Date received: 1979-07-26
Decision date: 1979-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DTR

product code DTR

Other: 1
Total: 1

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.