Deseret Flo-Thru Injectate Temperature Sensor
FDA 510(k) K862119 · Parke-Davis Co.
510(k) numberK862119
Submission
- Device name
- Deseret Flo-Thru Injectate Temperature Sensor
- Applicant
- Parke-Davis Co.
Rochester, MI, US - Received
- June 3, 1986
- Decision date
- August 29, 1986
- 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
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| 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 |
|---|---|---|
| K861725 | Intracath Intravenous Catheter Placement UnitFOZ · Traditional | 12/04/1986SE |
| K855120 | Ati Disposable Biological Test PackFRC · Traditional | 06/18/1986SE |
| K860570 | Angio-Flo Continuous Arterial Cath Flush DeviceKRA · Traditional | 03/31/1986SE |
| K860290 | Viapic Central Line CatheterFOZ · Traditional | 03/18/1986SE |
| K852192 | Disposable Steam Biological Test PackFRC · Traditional | 11/01/1985SE |
| K841967 | Deseret Thermodilution Cardiac OutputDXG · Traditional | 08/19/1985SE |
| K851327 | Deseret Arterial CatheterFOZ · Traditional | 06/14/1985SE |
| K852078 | Spectrum(Tentative)FOZ · Traditional | 06/07/1985SE |
| K844840 | Deseret Introducer SetDYB · Traditional | 05/16/1985SE |
| K850505 | Deseret Epidural Catheter W/Toughy-Borst AdapterBSO · Traditional | 03/11/1985SE |
Questions and answers
When was Deseret Flo-Thru Injectate Temperature Sensor cleared by the FDA?
Deseret Flo-Thru Injectate Temperature Sensor (K862119) received a 510(k) decision of Substantially Equivalent on August 29, 1986, 87 days after the submission was received.
What is the product code of K862119?
The FDA product code is DYG – Catheter, Flow Directed, a Class II (moderate risk) device regulated under 21 CFR 870.1240.