Terumo Pump Tubing
FDA 510(k) K150542 · Terumo Cardiovascular Systems Corporation
510(k) numberK150542
Submission
- Device name
- Terumo Pump Tubing
- Applicant
- Terumo Cardiovascular Systems Corporation
Ashland, MA, US - Received
- March 3, 2015
- Decision date
- May 1, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DWE – Tubing, Pump, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4390
- Specialty
- Cardiovascular
Other 510(k)s with product code DWE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233702 | SMARxT Tubing and ConnectorsDWE · Traditional | LivaNova USA, Inc. | 08/08/2024SE |
| K142607 | AngioVac CircuitDWE · Traditional | Angiodynamics | 12/11/2014SE |
| K092486 | Vortex Medical Angiovac Cardiopulmonary Bypass CircuitDWE · Traditional | Vortex Medical, Inc. | 08/28/2009SE |
| K080592 | HLM Tubing Set with Bioline CoatingDWE · Special | Maquet Cardiopulmonary, AG | 09/11/2008SE |
| K053025 | Jostra HLM Tubing SetDWE · Traditional | Maquet Cardiopulmonary, AG | 11/10/2005SE |
| K022857 | Pump Tubing with X-CoatingDWE · Special | Terumo Cardiovascular Systems Corporation | 09/19/2002SE |
| K013578 | Pump TubingDWE · Traditional | Terumo Cardiovascular Systems Corp. | 01/22/2002SE |
| K993189 | Cardiopulmonary Bypass Pump Tubing - 1/4 Inch Tubing, Cardiopulmonary Bypass Pump Tubing…DWE · Traditional | Terumo Corp. | 03/01/2000SE |
| K993062 | Chest Drainage TubingDWE · Traditional | Olson Medical Sales, Inc. | 12/10/1999SE |
| K981613 | Cobe Smarxt Tubing and ConnectorsDWE · Traditional | Cobe Cardiovascular, Inc. | 10/26/1998SE |
More from Cobe Cardiovascular, 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 |
| 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 Terumo Pump Tubing cleared by the FDA?
Terumo Pump Tubing (K150542) received a 510(k) decision of Substantially Equivalent on May 1, 2015, 59 days after the submission was received.
What is the product code of K150542?
The FDA product code is DWE – Tubing, Pump, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4390.