CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE— 510(k) K963758

Substantially Equivalent

Sorin Biomedical, Inc.

FDA 510(k) clearance K963758 for CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE, Substantially Equivalent on 1998-02-20. Applicant: Sorin Biomedical, Inc..

Clearance details

Applicant: Sorin Biomedical, Inc.
Product code: Code CAC
Advisory panel: Anesthesiology
Date received: 1996-09-18
Decision date: 1998-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, 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.