AngioVac Circuit
FDA 510(k) K142607 · Angiodynamics
510(k) numberK142607
Submission
- Device name
- AngioVac Circuit
- Applicant
- Angiodynamics
Marlborough, MA, US - Received
- September 15, 2014
- Decision date
- December 11, 2014
- 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 |
| 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 |
|---|---|---|
| K253198 | NanoKnife Generator (H78720300351US0)OAB · Traditional | 03/24/2026SE |
| K252509 | AlphaVac Multipurpose Mechanical Aspiration System F1885QEZ · Traditional | 11/24/2025SE |
| K253106 | AngioVac CannulaDWF · Special | 10/24/2025SE |
| K242687 | NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15…OAB · Traditional | 12/06/2024SE |
| K240397 | AlphaVac MMA F1885 System (H787253020)QEZ · Traditional | 04/01/2024SE |
| K231945 | VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure KitsGEX · Special | 07/20/2023SE |
| K223581 | Solero Microwave Tissue Ablation (MTA) System and AccessoriesNEY · Special | 03/27/2023SE |
| K221883 | Solero Microwave Tissue Ablation (MTA) System and AccessoriesNEY · Special | 03/07/2023SE |
| K213388 | AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 SystemQEZ · Traditional | 04/04/2022SE |
| K213067 | Solero Microwave Tissue Ablation (MTA) System and AccessoriesNEY · Special | 12/03/2021SE |
Questions and answers
When was AngioVac Circuit cleared by the FDA?
AngioVac Circuit (K142607) received a 510(k) decision of Substantially Equivalent on December 11, 2014, 87 days after the submission was received.
What is the product code of K142607?
The FDA product code is DWE – Tubing, Pump, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4390.