Medrad High Pressure Conecting Tube
FDA 510(k) K810924 · Medrad, Inc.
510(k) numberK810924
Submission
- Device name
- Medrad High Pressure Conecting Tube
- Applicant
- Medrad, Inc.
Mchenry, IL, US - Received
- April 6, 1981
- Decision date
- April 17, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
More from Olson Medical Sales, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K133023 | Jetstream XC 2.4/3.4; Jetstream XC 2.1/3.0; Jetstream SC 1.85; Jetstream SC 1.6MCW · Traditional | 08/27/2014SE |
| K130381 | Angiojet Ultra Power Pulse KitQEW · Traditional | 07/29/2013SE |
| K130637 | Jetstream XC 2.4/3.4 System; Jetstream XC 2.1/3.0 System; Jetstream SC 1.85 System…MCW · Special | 04/10/2013SE |
| K122916 | Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF System Jetstream SF…MCW · Special | 10/19/2012SE |
| K113363 | Angiojet Solent Dista Thrombectomy SetQEZ · Traditional | 06/06/2012SE |
| K113133 | Medrad Mark 7 Arterion (Pedestal System), (Table Mount System), Medrad Mark 7 Arterion…DXT · Special | 12/15/2011SE |
| K113428 | Angiojet Ultra DVX Thrombectomy SetQEZ · Special | 12/02/2011SE |
| K112086 | Medrad Mark 7 Arterion (Pedestal System / Table Mount System), Medrad Mark 7 Arterion…DXT · Special | 10/14/2011SE |
| K111182 | Angiojet Solent Omni Thrombectomy SetQEZ · Special | 05/24/2011SE |
| K100798 | Medrad Intego PET Infusion System, Source Administration Set, Patient Adminstratin Set…FRN · Traditional | 06/23/2010SE |
Questions and answers
When was Medrad High Pressure Conecting Tube cleared by the FDA?
Medrad High Pressure Conecting Tube (K810924) received a 510(k) decision of Substantially Equivalent on April 17, 1981, 11 days after the submission was received.
What is the product code of K810924?
The FDA product code is DWE – Tubing, Pump, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4390.