Reconnaissance PV.018 OTW Digital Ivus Catheter
Reconnaissance PV.018 OTW is an intravascular ultrasound catheter for cross-sectional imaging of peripheral vessel lumens and walls alongside angiography. Its distal 64-element cylindrical…
Reconnaissance PV.018 OTW is an intravascular ultrasound catheter for cross-sectional imaging of peripheral vessel lumens and walls alongside angiography. Its distal 64-element cylindrical array emits ultrasound and receives echoes for real-time image formation.
The catheter has a 150 cm working length with hydrophilic coating on the distal 40 cm. It accepts guidewires up to 0.018 inch and requires a guide sheath with a minimum 0.074 inch inner diameter.
Imaging Connection
A proximal Y-arm preserves the over-the-wire path while routing transducer wiring to the patient-interface module. The catheter evaluates peripheral vascular morphology and is not indicated for cerebral vessels.
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 | Philips Image Guided Therapy Corporation, 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) | K200410 |
| Record published | 2021-07-29 |
| Record revised | 2024-08-20 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep dry; Special storage condition: Keep away from sunlight |
| Sizes | Outer diameter 0.032 in; length 150 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 018OTW | Outer Diameter.032 in | 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 |
|---|---|
| K251103 | 2025-05-09 |
| K200812 | 2020-09-02 |
| K200410 | 2020-05-22 |
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.