Cleared Special

ACCESS CONCENTRATION SYSTEM, MODEL ACC-100, ACCESS DISPOSABLE SET, MODEL ADS-2000

K022348 · Interpore Cross Intl. · Anesthesiology
Aug 2002
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K022348 is an FDA 510(k) clearance for the ACCESS CONCENTRATION SYSTEM, MODEL ACC-100, ACCESS DISPOSABLE SET, MODEL ADS-2000, a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC), submitted by Interpore Cross Intl. (Irvine, US). The FDA issued a Cleared decision on August 15, 2002, 27 days after receiving the submission on July 19, 2002. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5830.

Submission Details

510(k) Number K022348 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 2002
Decision Date August 15, 2002
Days to Decision 27 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CAC — Apparatus, Autotransfusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5830

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