510(k) K221895
- Device
- Terumo Advanced Perfusion System 1
- Applicant
- Terumo Cardiovascular Systems Corporation
- 510(k) number
- K221895
- Product code
- DTQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-04-18
- Date received
- 2022-06-30
- Regulation
- 870.4220
- Classification name
- Console, Heart-Lung Machine, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Eileen Dorsey
- Address
- 6200 Jackson Rd. Ann Arbor MI US 48103 48103
FDA Registration Numbers
- 3009507273
- 3011554160
- 3006073153
- 1218444
- 2916596
- 2184009
- 3001589655
- 3010703925
- 3002807090
- 9680841
- 3010163695
- 3019807891
- 3042990265
- 3005941719
- 1828100
- 8010762
- 9611109
- 3007427881
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00886799002087 | Terumo® Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2023-11-03 |
| 00886799002070 | Terumo® Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2023-11-03 |
| 00886799002063 | Terumo® Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2023-11-03 |
| 00886799002056 | Terumo® Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2023-11-03 |
| 00886799001806 | Terumo® Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2023-08-01 |
| 00886799001844 | Terumo® Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2023-06-20 |
| 00886799001837 | Terumo® Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2023-06-20 |
| 00886799001820 | Terumo® Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2023-05-24 |
| 00886799001813 | Terumo® Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2023-05-18 |
Other 510(k) Records For Product Code DTQ
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232291 | Essenz HLM, Essenz ILBM | Livanova Deutschland, GmbH | 2023-08-24 |
| K221373 | Essenz HLM | Livanova Deutschland, GmbH | 2023-03-09 |
| K210130 | Stockert S5 System | Livanova Deutschland, GmbH | 2021-04-05 |
| K202125 | Century Perfusion System | Century Hlm, LLC | 2021-03-07 |
| K190282 | Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) | Spectrum Medical , Ltd. | 2019-05-24 |
| K173834 | Quantum Pump Console | Spectrum Medical , Ltd. | 2018-05-25 |
| K172220 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2017-08-17 |
| K163531 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2017-06-07 |
| K153376 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2015-12-16 |
| K151349 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2015-08-27 |
| K133598 | CARDIOHELP SYSTEM | Maquet Cardiopulmonary, AG | 2014-05-21 |
| K131041 | ADVANCED PERFUSION SYSTEM 1 | Terumo Cardiovascular Systems Corp. | 2014-02-20 |
| K102726 | CARDIOHELP SYSTEM | Maquet Cardiopulmonary, AG | 2011-04-04 |
| 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 | 2011-01-20 |
| K093882 | SORIN C5 SYSTEM MODEL 58-00-00 | Sorin Group Deutschland GmbH | 2010-01-15 |