Nuvision NAV Ultrasound Catheter
The Nuvision NAV Ultrasound Catheter provides intracardiac and intraluminal images of the heart, great vessels and other devices in the heart. It is a sterile, single-use 10F imaging…
The Nuvision NAV Ultrasound Catheter provides intracardiac and intraluminal images of the heart, great vessels and other devices in the heart. It is a sterile, single-use 10F imaging catheter that also supplies location information to a compatible CARTO 3 navigation system.
A two-dimensional acoustic array and integrated electronics at the distal tip produce real-time two-dimensional, three-dimensional and multiplane views. Handle knobs independently control catheter deflection and transducer rotation, with the imaging field extending sideways from the tip.
Listed Item
NUVISION NAV Ultrasound Catheter, 10F
Compatible Systems
The catheter is validated for the GE Vivid S70N ultrasound system and CARTO 3 with CARTOSOUND 4D, connected through the specified cables. It provides imaging guidance and location, not treatment delivery.
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Philips Ultrasound (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 5 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Jiangsu Tingsn Technology Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 4 |
| Nanjing Shuangwei Biotechnology Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 1 |
Record
| Listed by | Biosense Webster, Inc., United States |
|---|---|
| FDA product code | OBJ |
| Device type | Catheter, Ultrasound, Intravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K223766 |
| Record published | 2023-07-03 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Liquid-tight (catheter shaft only); Special storage condition: Keep away from Sunlight; Storage environment temperature -30 to 60 °C; Special storage condition: Keep dry; Special storage condition: Do not use if package is damaged; Handling environment humidity 10 to 90 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FG11656 | In distribution | |
| FG12081 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 27 |
| Acist HDi® HD Ivus System | Acist Medical Systems, Inc. | 8 |
| Soundstar | Biosense Webster, Inc. | 6 |
| OptiCross | Boston Scientific Corporation | 4 |
| Busse Hospital Disposables | Robert Busse & Co., Inc. | 4 |
| Acist HDi® System Console | Acist Medical Systems, Inc. | 4 |
| OptiCross™ 6 | Boston Scientific Corporation | 3 |
| 7 Fr PV-Catheter | CD Leycom | 3 |
| NES Reprocessed Visions PV.014P RX Digital Ivus Catheter | North East Scientific Inc | 3 |
| OptiCross™ 6 HD | Boston Scientific Corporation | 2 |
| Acist HDi® Bed Rail Mount | Acist Medical Systems, Inc. | 2 |
| 4 Fr PV Catheter | CD Leycom | 2 |
Showing 12 of 63. All products under Catheter, Ultrasound, Intravascular
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241540 | 2024-06-28 |
| K240050 | 2024-06-12 |
| K223766 | 2023-02-16 |
| K140318 | 2014-03-12 |
| K112050 | 2011-11-18 |
| K101138 | 2010-06-22 |
| K091352 | 2009-12-04 |
| K092064 | 2009-08-07 |
| K070242 | 2007-05-15 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-09-10 | Class II | Device Design | Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial effusion. Affects the CARTOSOUND Module of the CARTO 3 EP Navigation System when us | 1035 (U.S.) | 2016-05-13 |
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.