Physiological Pressure Measurement Sys
FDA 510(k) K830638 · Camino Laboratories, Inc.
510(k) numberK830638
Submission
- Device name
- Physiological Pressure Measurement Sys
- Applicant
- Camino Laboratories, Inc.
Walker, MI, US - Received
- March 1, 1983
- Decision date
- April 18, 1983
- 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 |
|---|---|---|
| K932769 | Camino Ventricular Drainage SystemJXG · Traditional | 03/30/1995SE |
| K930222 | Camino Ventricular Access DeviceJXG · Traditional | 04/15/1993SE |
| K930221 | Camino Ventricular Transducer AccessoryGWM · Traditional | 04/15/1993SE |
| K920088 | Camino Ventricular NeedleHCD · Traditional | 05/01/1992SE |
| K914735 | Ventricular Pressure Monitoring Kit, Model 110-4HMGWM · Traditional | 01/17/1992SE |
| K912833 | Camino Model M420: Monit Inter W/Mean Pres DisplayDSK · Traditional | 09/23/1991SE |
| K893232 | Model V420 Direct Pressure Monitor & 427 WaveformDSK · Traditional | 07/14/1989SE |
| K881183 | Ventricular Bolt Pressure Monitoring Kit #110-4HGWM · Traditional | 05/04/1988SE |
| K863969 | Camino Compartmental Press Monitor CATH/110-4DDXO · Traditional | 05/27/1987SE |
| K861961 | Camino CSF Drainage System Model 040JXG · Traditional | 08/12/1986SE |
Questions and answers
When was Physiological Pressure Measurement Sys cleared by the FDA?
Physiological Pressure Measurement Sys (K830638) received a 510(k) decision of Substantially Equivalent on April 18, 1983, 48 days after the submission was received.
What is the product code of K830638?
The FDA product code is DXO – Transducer, Pressure, Catheter Tip, a Class II (moderate risk) device regulated under 21 CFR 870.2870.