HLM Tubing Set with Bioline Coating
FDA 510(k) K080592 · Maquet Cardiopulmonary, AG
510(k) numberK080592
Submission
- Device name
- HLM Tubing Set with Bioline Coating
- Applicant
- Maquet Cardiopulmonary, AG
Hirrlingen, DE - Received
- March 3, 2008
- Decision date
- September 11, 2008
- 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 |
| 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 |
| 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 |
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| K133265 | Quadrox-Ir Adult and Small AdultKFM · Special | 11/12/2013SE |
| K132166 | Venous Hardshell Cardiotomy Reservoir; Non-Coated, Non-Tight/ Vacuum-Tight/ with…DTN · Special | 10/30/2013SE |
| K132829 | Quadrox-I, Quadrox-Id, Quadrox-Ir OxygenatorsDTZ · Special | 10/08/2013SE |
| K131666 | Arterial HLS Cannula 13 FR Non-Coated, with Bioline Coating and with Softline CoatingDWF · Special | 07/05/2013SE |
| K130300 | Heater-Cooler Unit Hcu 40DWC · Traditional | 07/01/2013SE |
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Questions and answers
When was HLM Tubing Set with Bioline Coating cleared by the FDA?
HLM Tubing Set with Bioline Coating (K080592) received a 510(k) decision of Substantially Equivalent on September 11, 2008, 192 days after the submission was received.
What is the product code of K080592?
The FDA product code is DWE – Tubing, Pump, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4390.