Balloon Wedge Pressure, Angiographic
FDA 510(k) K822806 · Nova Medical Specialties
510(k) numberK822806
Submission
- Device name
- Balloon Wedge Pressure, Angiographic
- Applicant
- Nova Medical Specialties
Walker, MI, US - Received
- September 17, 1982
- Decision date
- November 1, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DYG – Catheter, Flow Directed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1240
- Specialty
- Cardiovascular
Other 510(k)s with product code DYG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242451 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…DYG · Traditional | Edwards Lifesciences | 12/09/2024SE |
| K233983 | Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5)…DYG · Traditional | Edwards Lifesciences | 06/27/2024SE |
| K233824 | Swan-Ganz catheterDYG · Traditional | Edwards Lifesciences, LLC | 06/06/2024SE |
| K231248 | Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…DYG · Traditional | Edwards Lifesciencess, LLC | 09/21/2023SE |
| K222117 | Swang-Ganz IQ pulmonary artery catheterDYG · Traditional | Edwards Lifesiences, LLC | 12/09/2022SE |
| K193466 | Swan-Ganz CathetersDYG · Traditional | Edwards Lifesciences, LLC | 02/16/2020SE |
| K160084 | Swan Ganz CathetersDYG · Traditional | Edwards Lifesciences, LLC | 05/03/2016SE |
| K094048 | Percupro Messenger Balloon CatheterDYG · Traditional | Cardiosolutions, Inc. | 07/14/2011SE |
| K081052 | Occlusion Balloon Catheter, Model VenosDYG · Traditional | Oscor, Inc. | 06/18/2008SE |
| K010253 | Angio Flow Thermodilution Catheter, Model AF-CATH-01; Angioflow Meter, Models HQ100 and…DYG · Traditional | Transonic Systems, Inc. | 03/19/2002SE |
More from Transonic Systems, Inc.
| 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 |
| 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 |
| K812761 | Flow-Directed Balloon ThermodilutionKRG · Traditional | 11/02/1981SE |
Questions and answers
When was Balloon Wedge Pressure, Angiographic cleared by the FDA?
Balloon Wedge Pressure, Angiographic (K822806) received a 510(k) decision of Substantially Equivalent on November 1, 1982, 45 days after the submission was received.
What is the product code of K822806?
The FDA product code is DYG – Catheter, Flow Directed, a Class II (moderate risk) device regulated under 21 CFR 870.1240.