HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM— 510(k) K101907

Substantially Equivalent

Haemonetics Corp.

FDA 510(k) clearance K101907 for HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM, Substantially Equivalent on 2010-12-03. Applicant: Haemonetics Corp..

Clearance details

Applicant: Haemonetics Corp.
Product code: Code CAC
Advisory panel: Anesthesiology
Date received: 2010-07-08
Decision date: 2010-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Braintree, MA, 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.