Disposable Catheter Pressure Transducer
FDA 510(k) K894033 · Deseret Medical, Inc.
510(k) numberK894033
Submission
- Device name
- Disposable Catheter Pressure Transducer
- Applicant
- Deseret Medical, Inc.
Sandy, UT, US - Received
- June 6, 1989
- Decision date
- October 17, 1989
- 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 |
|---|---|---|
| K913027 | Vessel DilatorDRE · Traditional | 11/27/1991SE |
| K904648 | Safe Syte I.V. Catheter Placement UnitFOZ · Traditional | 12/14/1990SE |
| K904121 | Vialon ObturatorFOZ · Traditional | 11/08/1990SE |
| K904122 | Insyte-A Arterial Catheterization UnitFOZ · Traditional | 10/04/1990SE |
| K900116 | Deseret Optima Intravascular CatheterFOZ · Traditional | 06/18/1990SE |
| K895735 | Deseret Multilumen Subclavian CatheterLYY · Traditional | 05/18/1990SE |
| K895734 | Deseret Intravascular CatheterFOZ · Traditional | 04/09/1990SE |
| K893406 | Deseret PRN AdapterKGZ · Traditional | 06/22/1989SE |
| K882798 | Multiflo AdapterFPA · Traditional | 07/18/1988SE |
| K882797 | Luer-Lok Multiflo AdapterFPA · Traditional | 07/18/1988SE |
Questions and answers
When was Disposable Catheter Pressure Transducer cleared by the FDA?
Disposable Catheter Pressure Transducer (K894033) received a 510(k) decision of Substantially Equivalent on October 17, 1989, 133 days after the submission was received.
What is the product code of K894033?
The FDA product code is DXO – Transducer, Pressure, Catheter Tip, a Class II (moderate risk) device regulated under 21 CFR 870.2870.