Acist RXi® Console With dPR
The ACIST RXi console with dPR is used with a Navvus catheter to obtain intravascular pressure measurements during assessment of coronary and peripheral artery disease. It computes and…
The ACIST RXi console with dPR is used with a Navvus catheter to obtain intravascular pressure measurements during assessment of coronary and peripheral artery disease. It computes and displays pressure indices that help physicians assess the physiological significance of arterial narrowing.
The console receives pressure measured beyond the lesion from the catheter and proximal aortic pressure through an interface to a separate hemodynamic system. Its software calculates fractional flow reserve during induced hyperemia and diastolic pressure ratio from resting pressure waveforms.
Listed Item
RXi Console with dPR, US (p/n: 800939-010 )
Measurement Options
The dPR option uses the diastolic portion of the pressure waveform without requiring induced hyperemia. The system is intended for catheterization laboratories 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 | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Packaging | Console, packaged |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 019994 | 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.