Nova Balloon Thermodilution Pressure Trans Cath
FDA 510(k) K860526 · Nova Medical Specialties
510(k) numberK860526
Submission
- Device name
- Nova Balloon Thermodilution Pressure Trans Cath
- Applicant
- Nova Medical Specialties
Indian Mills, NJ, US - Received
- February 11, 1986
- Decision date
- May 2, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXO – Transducer, Pressure, Catheter Tip
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2870
- Specialty
- Cardiovascular
Other 510(k)s with product code DXO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251367 | OptoMonitor 3DXO · Traditional | Opsens, Inc. | 01/16/2026SE |
| K241418 | OptoMonitor 3DXO · Traditional | Opsens, Inc. | 02/12/2025SE |
| K233904 | ACIST RXi System (016616); ACIST Navvus II Catheter (016675_DXO · Traditional | Acist Medical Systems, Inc. | 07/17/2024SE |
| K222216 | TruWave Disposable Pressure TransducerDXO · Traditional | Edwards Lifesciences, LLC | 12/22/2022SE |
| K202943 | OptoMonitor 3DXO · Traditional | Opsens, Inc. | 11/24/2020SE |
| K193620 | OptoMonitor 3DXO · Traditional | Opsens, Inc. | 06/18/2020SE |
| K193279 | Comet II Pressure GuidewireDXO · Special | Boston Scientific Corporation | 12/23/2019SE |
| K192340 | OptoMonitorDXO · Traditional | Opsens, Inc. | 12/12/2019SE |
| K190852 | Zurich Pressure Guidewire System Model 100DXO · Traditional | Zurich Medical, Inc. | 08/14/2019SE |
| K183413 | TruWave Disposable Pressure TransducerDXO · Traditional | Edwards Lifeciences, LLC | 05/01/2019SE |
More from Edwards Lifeciences, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K872770 | Dual-Thermistor Thermodilution Cath. & Infu. Cath.DYG · Traditional | 10/15/1987SE |
| K853625 | Nova Arterial Embolectomy CatheterDXE · Traditional | 01/15/1986SE |
| 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 Balloon Thermodilution Pressure Trans Cath cleared by the FDA?
Nova Balloon Thermodilution Pressure Trans Cath (K860526) received a 510(k) decision of Substantially Equivalent on May 2, 1986, 80 days after the submission was received.
What is the product code of K860526?
The FDA product code is DXO – Transducer, Pressure, Catheter Tip, a Class II (moderate risk) device regulated under 21 CFR 870.2870.