DTQ · Console, Heart-Lung Machine, Cardiopulmonary Bypass
Cardiovascular · 21 CFR 870.4220 · Class 2
Overview
| Product Code | DTQ |
|---|---|
| Device Name | Console, Heart-Lung Machine, Cardiopulmonary Bypass |
| Regulation | 21 CFR 870.4220 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| Life-Sustaining | Yes |
Identification
A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 52)
Showing 20 most recent of 52 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K232291 | Essenz HLM, Essenz ILBM | Livanova Deutschland, GmbH | Aug 24, 2023 | SESE |
| K221895 | Terumo Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | Apr 18, 2023 | SESE |
| K221373 | Essenz HLM | Livanova Deutschland, GmbH | Mar 9, 2023 | SESE |
| K210130 | Stockert S5 System | Livanova Deutschland, GmbH | Apr 5, 2021 | SESE |
| K202125 | Century Perfusion System | Century Hlm, LLC | Mar 7, 2021 | SESE |
| K190282 | Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) | Spectrum Medical , Ltd. | May 24, 2019 | SESE |
| K173834 | Quantum Pump Console | Spectrum Medical , Ltd. | May 25, 2018 | SESE |
| K172220 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | Aug 17, 2017 | SESE |
| K163531 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | Jun 7, 2017 | SESE |
| K153376 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | Dec 16, 2015 | SESE |
| K151349 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | Aug 27, 2015 | SESE |
| K133598 | CARDIOHELP SYSTEM | Maquet Cardiopulmonary, AG | May 21, 2014 | SESE |
| K131041 | ADVANCED PERFUSION SYSTEM 1 | Terumo Cardiovascular Systems Corp. | Feb 20, 2014 | SESE |
| K102726 | CARDIOHELP SYSTEM | Maquet Cardiopulmonary, AG | Apr 4, 2011 | SESE |
| K103762 | SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE | Sorin Group Deutschland GmbH | Jan 20, 2011 | SESE |
| K093882 | SORIN C5 SYSTEM MODEL 58-00-00 | Sorin Group Deutschland GmbH | Jan 15, 2010 | SESE |
| K092463 | SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM | Sorin Group Deutschland GmbH | Nov 5, 2009 | SESE |
| K090006 | LIFEBRIDGE B2T, MODEL 7001 | Lifebridge Medizintechnik AG | Oct 15, 2009 | SESE |
| K091007 | AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05 | Sorin Group Deutschland GmbH | Jul 2, 2009 | SESE |
| K080832 | STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER | Sorin Group Deutschland GmbH | Jul 30, 2008 | SESE |
Top Applicants
- Sorin Group Deutschland GmbH — 8 clearances
- Terumo Cardiovascular Systems Corporation — 5 clearances
- 3M Health Care, Sarns — 5 clearances
- Stoeckert Instrumente — 3 clearances
- Shiley, Inc. — 3 clearances
