PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM— 510(k) K022167

Substantially Equivalent

Pall Corp.

FDA 510(k) clearance K022167 for PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM, Substantially Equivalent on 2003-03-07. Applicant: Pall Corp..

Clearance details

Applicant: Pall Corp.
Product code: Code CAC
Advisory panel: Anesthesiology
Date received: 2002-07-03
Decision date: 2003-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Hills, NY, 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.