Advanced Perfusion System 1
FDA 510(k) K153376 · Terumo Cardiovascular Systems Corporation
510(k) numberK153376
Submission
- Device name
- Advanced Perfusion System 1
- Applicant
- Terumo Cardiovascular Systems Corporation
Ann Arbor, MI, US - Received
- November 23, 2015
- Decision date
- December 16, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTQ – Console, Heart-Lung Machine, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4220
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
Other 510(k)s with product code DTQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232291 | Essenz HLM, Essenz ILBMDTQ · Special | Livanova Deutschland, GmbH | 08/24/2023SE |
| K221895 | Terumo Advanced Perfusion System 1DTQ · Traditional | Terumo Cardiovascular Systems Corporation | 04/18/2023SE |
| K221373 | Essenz HLMDTQ · Traditional | Livanova Deutschland, GmbH | 03/09/2023SE |
| K210130 | Stockert S5 SystemDTQ · Special | Livanova Deutschland, GmbH | 04/05/2021SE |
| K202125 | Century Perfusion SystemDTQ · Traditional | Century Hlm, LLC | 03/07/2021SE |
| K190282 | Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)DTQ · Traditional | Spectrum Medical , Ltd. | 05/24/2019SE |
| K173834 | Quantum Pump ConsoleDTQ · Traditional | Spectrum Medical , Ltd. | 05/25/2018SE |
| K172220 | Advanced Perfusion System 1DTQ · Special | Terumo Cardiovascular Systems Corporation | 08/17/2017SE |
| K163531 | Advanced Perfusion System 1DTQ · Traditional | Terumo Cardiovascular Systems Corporation | 06/07/2017SE |
| K151349 | Advanced Perfusion System 1DTQ · Traditional | Terumo Cardiovascular Systems Corporation | 08/27/2015SE |
More from Terumo Cardiovascular Systems Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K234065 | CDI OneView Monitoring SystemDRY · Traditional | 04/25/2024SE |
| K221895 | Terumo Advanced Perfusion System 1DTQ · Traditional | 04/18/2023SE |
| K200091 | Capiox iCP Centrifugal PumpKFM · Traditional | 11/18/2021SE |
| K182110 | CDI Blood Parameter Monitoring System 550DRY · Traditional | 11/02/2018SE |
| K180950 | Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19…DTZ · Traditional | 06/22/2018SE |
| K172071 | Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19…DTZ · Traditional | 03/29/2018SE |
| K172220 | Advanced Perfusion System 1DTQ · Special | 08/17/2017SE |
| K163531 | Advanced Perfusion System 1DTQ · Traditional | 06/07/2017SE |
| K162843 | Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump…DWB · Special | 11/17/2016SE |
| K160206 | VirtuoSaph Plus Endoscopic Vessel Harvesting SystemGEI · Traditional | 04/21/2016SE |
Questions and answers
When was Advanced Perfusion System 1 cleared by the FDA?
Advanced Perfusion System 1 (K153376) received a 510(k) decision of Substantially Equivalent on December 16, 2015, 23 days after the submission was received.
What is the product code of K153376?
The FDA product code is DTQ – Console, Heart-Lung Machine, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4220.