PPG Biomedical Flexible Micro Transducer Catheter
FDA 510(k) K883436 · Ppg Industries, Inc.
510(k) numberK883436
Submission
- Device name
- PPG Biomedical Flexible Micro Transducer Catheter
- Applicant
- Ppg Industries, Inc.
Pleasantville, NY, US - Received
- August 15, 1988
- Decision date
- October 17, 1988
- 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
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|---|---|---|---|
| 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 |
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| K912627 | Midas System 2500, Physiological Monitoring SystemMHX · Traditional | 09/10/1991SE |
| K903965 | Statpal Blood Gas Monitoring SystemCHL · Traditional | 12/26/1990SE |
| K901514 | XR Model H Physiological Monitor & Recording Sys.DSK · Traditional | 11/16/1990SE |
| K900246 | Cardiotest Ek 53 R, Cardiognost Ek 56/ Ek 512DSI · Traditional | 07/03/1990SE |
| K901132 | Sara SatcapCCK · Traditional | 05/22/1990SE |
| K896442 | PPG Biomedical Ventilator Model IrisaCBK · Traditional | 04/16/1990SE |
| K900700 | Smu 611 UniversalmonitorDPS · Traditional | 04/03/1990SE |
Questions and answers
When was PPG Biomedical Flexible Micro Transducer Catheter cleared by the FDA?
PPG Biomedical Flexible Micro Transducer Catheter (K883436) received a 510(k) decision of Substantially Equivalent on October 17, 1988, 63 days after the submission was received.
What is the product code of K883436?
The FDA product code is DXO – Transducer, Pressure, Catheter Tip, a Class II (moderate risk) device regulated under 21 CFR 870.2870.