Cleared Special

Stockert S5 System

K210130 · Livanova Deutschland, GmbH · Cardiovascular
Apr 2021
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K210130 is an FDA 510(k) clearance for the Stockert S5 System, a Console, Heart-lung Machine, Cardiopulmonary Bypass (Class II — Special Controls, product code DTQ), submitted by Livanova Deutschland, GmbH (Munich, DE). The FDA issued a Cleared decision on April 5, 2021, 76 days after receiving the submission on January 19, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4220.

Submission Details

510(k) Number K210130 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 2021
Decision Date April 05, 2021
Days to Decision 76 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DTQ — Console, Heart-lung Machine, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4220

Similar Devices — DTQ Console, Heart-lung Machine, Cardiopulmonary Bypass

All 51
Essenz HLM, Essenz ILBM
K232291 · Livanova Deutschland, GmbH · Aug 2023
Terumo Advanced Perfusion System 1
K221895 · Terumo Cardiovascular Systems Corporation · Apr 2023
Essenz HLM
K221373 · Livanova Deutschland, GmbH · Mar 2023
Century Perfusion System
K202125 · Century Hlm, LLC · Mar 2021
Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)
K190282 · Spectrum Medical , Ltd. · May 2019
Quantum Pump Console
K173834 · Spectrum Medical , Ltd. · May 2018