Cleared Traditional

CELL SAVER ELITE

K120586 · Haemonetics Corp. · Anesthesiology
May 2012
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K120586 is an FDA 510(k) clearance for the CELL SAVER ELITE, 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 May 22, 2012, 85 days after receiving the submission on February 27, 2012. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5830.

Submission Details

510(k) Number K120586 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 2012
Decision Date May 22, 2012
Days to Decision 85 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

Similar Devices — CAC Apparatus, Autotransfusion

All 194
XTRA Collection sets; XTRA Sequestration set X
K241236 · Sorin Group Italia S.R.L. · Aug 2024
Aventus Clot Management System
K240426 · Inquis Medical · May 2024
XTRA Autotransfusion System (with XTRA Bowl sets)
K240584 · Sorin Group Italia S.R.L. · Apr 2024
FlowSaver Blood Return System (80-101)
K231782 · Inari Medical, Inc. · Jul 2023
FlowSaver Blood Return System
K221483 · Inari Medical, Inc. · Feb 2023
Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)
K221722 · Haemonetics Corporation · Nov 2022