Transducer, Pressure, Catheter Tip
FDA 510(k) K920580 · Medamicus, Inc.
510(k) numberK920580
Submission
- Device name
- Transducer, Pressure, Catheter Tip
- Applicant
- Medamicus, Inc.
Minneapolis, MN, US - Received
- February 10, 1992
- Decision date
- January 7, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K040150 | Modification to Medamicus Flowguard Peelable IntroducerDYB · Special | 02/18/2004SE |
| K030905 | Medamicus Flowguard Peelable IntroducerDYB · Special | 04/09/2003SE |
| K022689 | Modification to Medamicus Axia RSNDYB · Special | 08/23/2002SE |
| K021004 | Valved Peelable IntroducerDYB · Traditional | 06/06/2002SE |
| K020563 | Medamicus Axia RSNDYB · Traditional | 05/21/2002SE |
| K013120 | Percutaneous Introducer Set, Model 042294 and Kit Model 3550-18GZB · Traditional | 01/24/2002SE |
| K011085 | Guidewire Introducer Safety NeedleDYB · Traditional | 07/09/2001SE |
| K000824 | Percutaneous Introducer, Model 10383-XXXDYB · Special | 04/13/2000SE |
| K994097 | Medamicus Epidural IntroducerGZB · Traditional | 03/01/2000SE |
| K990705 | Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator SetDYB · Traditional | 06/28/1999SE |
Questions and answers
When was Transducer, Pressure, Catheter Tip cleared by the FDA?
Transducer, Pressure, Catheter Tip (K920580) received a 510(k) decision of Substantially Equivalent on January 7, 1993, 332 days after the submission was received.
What is the product code of K920580?
The FDA product code is DXO – Transducer, Pressure, Catheter Tip, a Class II (moderate risk) device regulated under 21 CFR 870.2870.