Cleared Traditional

HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM

K101907 · Haemonetics Corp. · Anesthesiology
Dec 2010
Decision
148d
Days
Class 2
Risk

About This 510(k) Submission

K101907 is an FDA 510(k) clearance for the HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM, a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC), submitted by Haemonetics Corp. (Braintree, US). The FDA issued a Cleared decision on December 3, 2010, 148 days after receiving the submission on July 8, 2010. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5830.

Submission Details

510(k) Number K101907 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 2010
Decision Date December 03, 2010
Days to Decision 148 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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