Cleared Traditional

Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)

K221722 · Haemonetics Corporation · Cardiovascular
Nov 2022
Decision
154d
Days
Class 2
Risk

About This 510(k) Submission

K221722 is an FDA 510(k) clearance for the Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US), a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC), submitted by Haemonetics Corporation (Boston, US). The FDA issued a Cleared decision on November 15, 2022, 154 days after receiving the submission on June 14, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 868.5830.

Submission Details

510(k) Number K221722 FDA.gov
FDA Decision Cleared SESE
Date Received June 14, 2022
Decision Date November 15, 2022
Days to Decision 154 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
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
Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain
K201305 · Atrium Medical Corporation · Sep 2021