SORIN BLOOD CARDIOPLEGIA CONSOLE— 510(k) K942582

Substantially Equivalent

Sorin Biomedical, Inc.

FDA 510(k) clearance K942582 for SORIN BLOOD CARDIOPLEGIA CONSOLE, Substantially Equivalent on 1995-01-27. Applicant: Sorin Biomedical, Inc..

Clearance details

Applicant: Sorin Biomedical, Inc.
Product code: Code DTQ
Advisory panel: Cardiovascular
Date received: 1994-06-01
Decision date: 1995-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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Adverse events under product code DTQ

product code DTQ

Death: 123
Malfunction: 4,822
Other: 1
Total: 4,946

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.