Acist RXi® System With dPR
The ACIST RXi System with dPR measures blood pressure within coronary and peripheral arteries to support assessment of narrowed vessels. It works with a Navvus pressure-sensing catheter and…
The ACIST RXi System with dPR measures blood pressure within coronary and peripheral arteries to support assessment of narrowed vessels. It works with a Navvus pressure-sensing catheter and a console that displays and analyzes the pressure measurements.
The catheter measures pressure beyond a lesion, while an interface to a separate hemodynamic system supplies proximal aortic pressure. The console compares these pressures to calculate fractional flow reserve during induced hyperemia or diastolic pressure ratio at rest.
Listed Item
RXi System with dPR, US (p/n: 800981-010 )
Measurement Modes
The dPR mode uses the diastolic portion of the pressure waveform for physiological assessment without inducing hyperemia. Users can select dPR or the existing FFR mode. The system is intended for catheterization and related cardiovascular specialty laboratories.
Who Else Makes It
Concentrated in Shanghai (1), Guangdong (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Beijing Bywave Sensing Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
Record
| Listed by | Acist Medical Systems, Inc., United States |
|---|---|
| FDA product code | DXO |
| Device type | Transducer, Pressure, Catheter Tip |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2870 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K233904 |
| Record published | 2025-01-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 019995 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Truwave | Edwards Lifesciences Technology Sarl | 456 |
| OptoMonitor 3 | Opsens Inc. | 73 |
| Truwave, Vamp | Edwards Lifesciences Technology Sarl | 45 |
| Truwave, Vamp Plus | Edwards Lifesciences Technology Sarl | 24 |
| PX1800 → Truwave Cables | Edwards Lifesciences Technology Sarl | 22 |
| Truwave, Vamp JR | Edwards Lifesciences Technology Sarl | 12 |
| Truwave Cables | Edwards Lifesciences Technology Sarl | 7 |
| TruWave, Vamp Plus | Becton, Dickinson AND Company | 5 |
| TruWave | Becton, Dickinson AND Company | 4 |
| Comet | Boston Scientific Corporation | 4 |
| Medline Industries, Inc. | Medline Industries, Inc. | 4 |
| Pressure Tubing | Edwards Lifesciences Technology Sarl | 3 |
Showing 12 of 63. All products under Transducer, Pressure, Catheter Tip
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233904 | 2024-07-17 |
| K132474 | 2014-01-30 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.