INTRAOPERATIVE AUTOTRANSFUSION SYS— 510(k) K831557

Substantially Equivalent

Thoratec Laboratories Corp.

FDA 510(k) clearance K831557 for INTRAOPERATIVE AUTOTRANSFUSION SYS, Substantially Equivalent on 1983-08-24. Applicant: Thoratec Laboratories Corp..

Clearance details

Applicant: Thoratec Laboratories Corp.
Product code: Code CAC
Advisory panel: Anesthesiology
Date received: 1983-05-16
Decision date: 1983-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code CAC

product code CAC

Death: 11
Malfunction: 477
Total: 488

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.