Cardiopulmonary Bypass Pump Tubing - 1/4 Inch Tubing, Cardiopulmonary Bypass Pump Tubing - 3/8 Inch Tubing
FDA 510(k) K993189 · Terumo Corp.
510(k) numberK993189
Submission
- Device name
- Cardiopulmonary Bypass Pump Tubing - 1/4 Inch Tubing, Cardiopulmonary Bypass Pump Tubing - 3/8 Inch Tubing
- Applicant
- Terumo Corp.
Elkton, MD, US - Received
- September 23, 1999
- Decision date
- March 1, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| K150542 | Terumo Pump TubingDWE · Special | Terumo Cardiovascular Systems Corporation | 05/01/2015SE |
| 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 |
| 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 |
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Questions and answers
When was Cardiopulmonary Bypass Pump Tubing - 1/4 Inch Tubing, Cardiopulmonary Bypass Pump Tubing - 3/8 Inch Tubing cleared by the FDA?
Cardiopulmonary Bypass Pump Tubing - 1/4 Inch Tubing, Cardiopulmonary Bypass Pump Tubing - 3/8 Inch Tubing (K993189) received a 510(k) decision of Substantially Equivalent on March 1, 2000, 160 days after the submission was received.
What is the product code of K993189?
The FDA product code is DWE – Tubing, Pump, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4390.