Cleared Traditional

ACCESS SEQUESTRATION SYSTEM

K012406 · Interpore Cross Intl. · Anesthesiology
Mar 2002
Decision
239d
Days
Class 2
Risk

About This 510(k) Submission

K012406 is an FDA 510(k) clearance for the ACCESS SEQUESTRATION SYSTEM, a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC), submitted by Interpore Cross Intl. (Irvine, US). The FDA issued a Cleared decision on March 26, 2002, 239 days after receiving the submission on July 30, 2001. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5830.

Submission Details

510(k) Number K012406 FDA.gov
FDA Decision Cleared SESE
Date Received July 30, 2001
Decision Date March 26, 2002
Days to Decision 239 days
Submission Type Traditional
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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