HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS CELLSEVER HAEMOLITE 2 FAMILY OF AUTOLOGOUS BLOOD RECOVER— 510(k) K993581

Substantially Equivalent

Haemonetics Corp.

FDA 510(k) clearance K993581 for HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS CELLSEVER HAEMOLITE 2 FAMILY OF AUTOLOGOUS BLOOD RECOVER, Substantially Equivalent on 1999-11-18. Applicant: Haemonetics Corp..

Clearance details

Applicant: Haemonetics Corp.
Product code: Code CAC
Advisory panel: Anesthesiology
Date received: 1999-10-22
Decision date: 1999-11-18
Decision: Substantially Equivalent
Clearance type: Special
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.