Cleared Traditional

STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM

K101046 · Sorin Group Deutschland GmbH · Cardiovascular
Dec 2010
Decision
239d
Days
Class 2
Risk

About This 510(k) Submission

K101046 is an FDA 510(k) clearance for the STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM, a Gas Control Unit, Cardiopulmonary Bypass (Class II — Special Controls, product code DTX), submitted by Sorin Group Deutschland GmbH (North Attleboro, US). The FDA issued a Cleared decision on December 9, 2010, 239 days after receiving the submission on April 14, 2010. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4300.

Submission Details

510(k) Number K101046 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 2010
Decision Date December 09, 2010
Days to Decision 239 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DTX — Gas Control Unit, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4300

Similar Devices — DTX Gas Control Unit, Cardiopulmonary Bypass

All 9
Quantum Mini Ventilation Module
K210669 · Spectrum Medical , Ltd. · May 2021
Quantum Ventilation Module
K202733 · Spectrum Medical , Ltd. · Oct 2020
Quantum Ventilation Module
K181942 · Spectrum Medical , Ltd. · Oct 2018
SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G
K023745 · Sechrist Industries, Inc. · Jan 2003
COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002)
K965214 · Coeur Laboratories, Inc. · Mar 1997
MODIFIED SARNS MEMBRANE OXYGENATOR
K863902 · 3M Health Care, Sarns · Dec 1986