Cleared Traditional

PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM

K022167 · Pall Corp. · Anesthesiology

Mar 2003

Decision

247d

Days

Class 2

Risk

About This 510(k) Submission

K022167 is an FDA 510(k) clearance for the PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM, a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC), submitted by Pall Corp. (East Hills, US). The FDA issued a Cleared decision on March 7, 2003, 247 days after receiving the submission on July 3, 2002. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5830.

Submission Details

510(k) Number	K022167 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 03, 2002
Decision Date	March 07, 2003
Days to Decision	247 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF