Nova Arterial Embolectomy Catheter
FDA 510(k) K853625 · Nova Medical Specialties
510(k) numberK853625
Submission
- Device name
- Nova Arterial Embolectomy Catheter
- Applicant
- Nova Medical Specialties
Indian Mills, NJ, US - Received
- August 29, 1985
- Decision date
- January 15, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXE – Catheter, Embolectomy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5150
- Specialty
- Cardiovascular
Other 510(k)s with product code DXE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240078 | Fogarty Thru-Lumen Embolectomy CatheterDXE · Traditional | Edwards Lifesciences, LLC | 08/28/2024SE |
| K241330 | Fogarty Fortis Arterial Embolectomy CatheterDXE · Traditional | Edwards Lifesciences | 07/02/2024SE |
| K233820 | Fogarty Arterial Embolectomy Catheter with Gate ValveDXE · Traditional | Edwards Lifesciences | 05/22/2024SE |
| K233819 | Fogarty Venous Thrombectomy CathetersDXE · Traditional | Edwards Lifesciences, LLC | 05/22/2024SE |
| K233619 | Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy CathetersDXE · Traditional | Edwards Lifesciences | 05/20/2024SE |
| K213771 | Merlin Aspiration SystemDXE · Traditional | Mivi Neurovascular, Inc. | 01/27/2022SE |
| K202049 | Python Catheter/Over-the-Wire Latis Graft Cleaning CatheterDXE · Special | Applied Medical Resources Corporation | 09/07/2021SE |
| K193379 | Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon ProbeDXE · Traditional | Edwards Lifesciences, LLC | 06/12/2020SE |
| K163031 | Bunegin-Albin Air Aspiration SetDXE · Traditional | Cook Incorporated | 07/27/2017SE |
| K163353 | Needle's Eye Snare Retrieval Set - 54cmDXE · Special | Cook Incorporated | 07/11/2017SE |
More from Cook Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K872770 | Dual-Thermistor Thermodilution Cath. & Infu. Cath.DYG · Traditional | 10/15/1987SE |
| K860526 | Nova Balloon Thermodilution Pressure Trans CathDXO · Traditional | 05/02/1986SE |
| K840009 | Nova 12 Cardiac Output ComputerDXG · Traditional | 08/22/1984SE |
| K841640 | Nova Balloon Thermodilution InfusionDYG · Traditional | 08/12/1984SE |
| K841639 | Nova Balloon Thermodilution Cath.DYG · Traditional | 08/12/1984SE |
| K834037 | Heparin Coated Balloon ThermodiluDYG · Traditional | 01/10/1984SE |
| K834036 | Heparin Coated Balloon ThermodiluDYG · Traditional | 01/10/1984SE |
| K832287 | Nova Balloon Thermodilution InfusionDYG · Traditional | 10/19/1983SE |
| K822806 | Balloon Wedge Pressure, AngiographicDYG · Traditional | 11/01/1982SE |
| K812761 | Flow-Directed Balloon ThermodilutionKRG · Traditional | 11/02/1981SE |
Questions and answers
When was Nova Arterial Embolectomy Catheter cleared by the FDA?
Nova Arterial Embolectomy Catheter (K853625) received a 510(k) decision of Substantially Equivalent on January 15, 1986, 139 days after the submission was received.
What is the product code of K853625?
The FDA product code is DXE – Catheter, Embolectomy, a Class II (moderate risk) device regulated under 21 CFR 870.5150.