Cleared Traditional

ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM

K122262 · Haemonetics Corp. · Anesthesiology
Oct 2012
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K122262 is an FDA 510(k) clearance for the ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM, a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC), submitted by Haemonetics Corp. (El Dorado Hills, US). The FDA issued a Cleared decision on October 25, 2012, 90 days after receiving the submission on July 27, 2012. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5830.

Submission Details

510(k) Number K122262 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 2012
Decision Date October 25, 2012
Days to Decision 90 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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