Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1
FDA 510(k) K162843 · Terumo Cardiovascular Systems Corporation
510(k) numberK162843
Submission
- Device name
- Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1
- Applicant
- Terumo Cardiovascular Systems Corporation
Ann Arbor, MI, US - Received
- October 11, 2016
- Decision date
- November 17, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DWB – Pump, Blood, Cardiopulmonary Bypass, Roller Type
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4370
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
Other 510(k)s with product code DWB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K131618 | Large (6) Roller Pump for Terumo Advanced Perfusion System 1; Large (6) Roller Pump for…DWB · Traditional | Terumo Cardiovascular Systems Corporation | 09/27/2013SE |
| K112587 | Advanced Perfusion System 1 (APS1) Tube Clamp Assembly, Roller Pump 6 Inch Classic Color,DWB · Traditional | Terumo Cardiovascular Systems Corp. | 12/19/2011SE |
| K973237 | Css-Cardioplegia Safety SystemDWB · Traditional | Medtronic Bio-Medicus, Inc. | 04/27/1998SE |
| K972321 | S3 Mast PumpDWB · Traditional | Stoeckert Instrumente | 02/27/1998SE |
| K971520 | S3 Cyclic RPM ControlDWB · Traditional | Stoeckert Instrumente | 09/10/1997SE |
| K960974 | Cobe Century Perfusion PumpDWB · Traditional | Cobe Cardiovascular, Inc. | 07/14/1997SE |
| K953904 | Sarns 9000 Universal Roller PumpDWB · Traditional | 3M Health Care, Ltd. | 04/19/1996SE |
| K953901 | Sarns 800 Roller PumpDWB · Traditional | 3M Health Care, Sarns | 04/19/1996SE |
| K955038 | Stockert S3 Double Head Pump ModuleDWB · Traditional | Stoeckert Instrumente | 02/21/1996SE |
| K890904 | Modified Stockert-Shiley Caps Multi. Roller PumpDWB · Traditional | Shiley, Inc. | 04/12/1989SE |
More from Shiley, Inc.
| 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 |
| K160206 | VirtuoSaph Plus Endoscopic Vessel Harvesting SystemGEI · Traditional | 04/21/2016SE |
| K153376 | Advanced Perfusion System 1DTQ · Special | 12/16/2015SE |
Questions and answers
When was Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1 cleared by the FDA?
Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1 (K162843) received a 510(k) decision of Substantially Equivalent on November 17, 2016, 37 days after the submission was received.
What is the product code of K162843?
The FDA product code is DWB – Pump, Blood, Cardiopulmonary Bypass, Roller Type, a Class II (moderate risk) device regulated under 21 CFR 870.4370.