DTQ — Console, Heart-Lung Machine, Cardiopulmonary Bypass Class II
FDA product code DTQ covers "Console, Heart-Lung Machine, Cardiopulmonary Bypass", a Class II medical device regulated under 21 CFR 870.4220. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DTQ
- Device Class
- Class II
- Regulation Number
- 870.4220
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K232291 | livanova deutschland | Essenz HLM, Essenz ILBM | August 24, 2023 |
| K221895 | terumo cardiovascular systems corporation | Terumo Advanced Perfusion System 1 | April 18, 2023 |
| K221373 | livanova deutschland | Essenz HLM | March 9, 2023 |
| K210130 | livanova deutschland | Stockert S5 System | April 5, 2021 |
| K202125 | century hlm | Century Perfusion System | March 7, 2021 |
| K190282 | spectrum medical | Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) | May 24, 2019 |
| K173834 | spectrum medical | Quantum Pump Console | May 25, 2018 |
| K172220 | terumo cardiovascular systems corporation | Advanced Perfusion System 1 | August 17, 2017 |
| K163531 | terumo cardiovascular systems corporation | Advanced Perfusion System 1 | June 7, 2017 |
| K153376 | terumo cardiovascular systems corporation | Advanced Perfusion System 1 | December 16, 2015 |
| K151349 | terumo cardiovascular systems corporation | Advanced Perfusion System 1 | August 27, 2015 |
| K133598 | maquet cardiopulmonary | CARDIOHELP SYSTEM | May 21, 2014 |
| K131041 | terumo cardiovascular systems | ADVANCED PERFUSION SYSTEM 1 | February 20, 2014 |
| K102726 | maquet cardiopulmonary | CARDIOHELP SYSTEM | April 4, 2011 |
| K103762 | sorin group deutschland | SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL W | January 20, 2011 |
| K093882 | sorin group deutschland | SORIN C5 SYSTEM MODEL 58-00-00 | January 15, 2010 |
| K092463 | sorin group deutschland | SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM | November 5, 2009 |
| K090006 | lifebridge medizintechnik | LIFEBRIDGE B2T, MODEL 7001 | October 15, 2009 |
| K091007 | sorin group deutschland | AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05 | July 2, 2009 |
| K080832 | sorin group deutschland | STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER | July 30, 2008 |