Mmi/Gaeltec Catheter Tip Transduc
FDA 510(k) K801756 · Medical Measurements, Inc.
510(k) numberK801756
Submission
- Device name
- Mmi/Gaeltec Catheter Tip Transduc
- Applicant
- Medical Measurements, Inc.
Mchenry, IL, US - Received
- July 28, 1980
- Decision date
- August 20, 1980
- 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 |
|---|---|---|
| K921062 | Gaeltec MPR SeriesFFX · Traditional | 07/30/1992SE |
| K902097 | Model TR Rectal Suction Biopsy TubeFCK · Traditional | 07/27/1990SE |
| K863479 | Modified Ict/B Intracranial Press. Trans. EpiduralGWM · Traditional | 10/14/1986SE |
| K801757 | Mmi/Gaeltec Catheter Tip Press. TransduFES · Traditional | 08/27/1980SE |
| K801880 | Mmi/Gaeltec Series 8T Diff. Press. TransBYR · Traditional | 08/14/1980SE |
| K801758 | Mmi/Gaeltec Catheter IntrauterineKXO · Traditional | 08/14/1980SE |
| K801755 | Mmi/Gaeltec Catheter Tip PressureGWM · Traditional | 08/13/1980SE |
Questions and answers
When was Mmi/Gaeltec Catheter Tip Transduc cleared by the FDA?
Mmi/Gaeltec Catheter Tip Transduc (K801756) received a 510(k) decision of Substantially Equivalent on August 20, 1980, 23 days after the submission was received.
What is the product code of K801756?
The FDA product code is DXO – Transducer, Pressure, Catheter Tip, a Class II (moderate risk) device regulated under 21 CFR 870.2870.