Acist Navvus® Catheter
Navvus Catheter is a pressure-sensing catheter used with the ACIST RXi System to obtain intravascular pressure measurements. The measurements support assessment of coronary and peripheral…
Navvus Catheter is a pressure-sensing catheter used with the ACIST RXi System to obtain intravascular pressure measurements. The measurements support assessment of coronary and peripheral artery disease in catheterization and cardiovascular laboratories.
An optical pressure sensor at the end of a fiber optic is integrated into a monorail catheter. The catheter carries the measured pressure signal to the RXi system, which converts the data into physiological measurements such as fractional flow reserve.
Listed Item
Navvus Catheter, p/n 701481-010
Catheter Placement
The catheter is designed to fit within a percutaneous guiding catheter for passage through a vessel. It is a single-patient sensing device used as the measurement component of the compatible RXi system.
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) | K132474 |
| Record published | 2017-08-15 |
| Record revised | 2019-10-18 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Shelf box, inner box of 5, pack of 5 |
| Distribution end date | 2019-04-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 014667 | Working Length: 150 Centimeter | In distribution |
| 014667 | Working Length: 150 Centimeter | Withdrawn |
| 014667 | Working Length: 150 Centimeter | Withdrawn |
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.