Cleared Traditional

Haemonetics Cell Saver Elite/Elite+ Autotransfusion System

K162423 · Haemonetics Corporation · Anesthesiology
Jan 2017
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K162423 is an FDA 510(k) clearance for the Haemonetics Cell Saver Elite/Elite+ Autotransfusion System, a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC), submitted by Haemonetics Corporation (Braintree, US). The FDA issued a Cleared decision on January 3, 2017, 126 days after receiving the submission on August 30, 2016. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5830.

Submission Details

510(k) Number K162423 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 2016
Decision Date January 03, 2017
Days to Decision 126 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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