Novasight Hybrid™ Catheter
Novasight Hybrid Catheter is an intravascular imaging catheter used with the Novasight Hybrid System to examine coronary arteries in adults undergoing transluminal interventions. It…
Novasight Hybrid Catheter is an intravascular imaging catheter used with the Novasight Hybrid System to examine coronary arteries in adults undergoing transluminal interventions. It combines ultrasound and optical coherence tomography imaging in one catheter.
The catheter acquires real-time, side-viewing two-dimensional ultrasound and optical images simultaneously. The corresponding images show vessel anatomy and the positions of other devices, such as stent struts. The imaging sensor can be positioned manually or moved through a defined region by pullback.
Listed Item
Imaging catheter consists of Novasight Hybrid Catheter, Accessory Pack and PIM Bag.
System Connection
The three-French catheter connects to the system’s Patient Interface Module. It is supplied sterile for single use; the console handles image acquisition, display and review.
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 | Conavi Medical Inc, Canada |
|---|---|
| FDA product code | OBJ |
| Device type | Catheter, Ultrasound, Intravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K172258 |
| Record published | 2023-04-17 |
| Record revised | 2022-11-09 (version 2) |
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 | Pack of 5, pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TA-06-0001 | In distribution | |
| TA-06-0001 | 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 |
|---|---|
| K252945 | 2026-04-17 |
| K172258 | 2018-04-27 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Conavi Medical Inc | 510(k) number | 2025-03-12 | Class I | Process control | Due to manufacturing issues there is a potential for the catheter sheath to detach. | 685 |
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.