NES Reprocessed Visions PV.014P RX Digital Ivus Catheter
The device is the Philips Vision PV .014P RX Digital IVUS catheter that is reprocessed by Northeast Scientific, Inc. (NES).
4manufacturers in China registered for this device type
3catalogue numbers in this listing
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 | North East Scientific Inc |
|---|---|
| FDA product code | OBJ |
| Device type | Catheter, Ultrasound, Intravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| 510(k) | K200195 |
| Record published | 2023-07-12 |
| Record revised | 2023-07-13 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Sizes | Catheter working length 150 cm; lumen/inner diameter 0.014 in; catheter gauge 3.5 Fr; introducer sheath compatibility 5 Fr |
| Distribution end date | 2030-11-24 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R-014R | Catheter Working Length 150 cm | In distribution |
| R-014R | Catheter Working Length 150 cm | In distribution |
| R-014R | Catheter Working Length 150 cm | Withdrawn |
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 |
| OptiCross™ 6 HD | Boston Scientific Corporation | 2 |
| Acist HDi® Bed Rail Mount | Acist Medical Systems, Inc. | 2 |
| 4 Fr PV Catheter | CD Leycom | 2 |
| Eagle Eye Platinum RX Digital Ivus Catheter | Philips Image Guided Therapy Corporation | 2 |
Showing 12 of 63. All products under Catheter, Ultrasound, Intravascular
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.