Niti-S Biliary Stent
The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary tree. The Niti-S Biliary Stent consists of an implantable metallic stent and a disposable,…
The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary tree. The Niti-S Biliary Stent consists of an implantable metallic stent and a disposable, flexible introducer system for placement of the stent. The stent is a flexible and expandable tubular device made of Nitinol wire that is intended to be implanted to restore the structure and/or function of the biliary system. The introducer is a disposable system for delivery and deployment of the stent at the target position. Upon deployment, the stent imparts an outward radial force on the luminal surface of the biliary system to establish and maintain patency. The stent is available in two diameters (8, 10mm), and eight lengths (40, 50, 60, 70, 80, 90, 100, 120mm). The stent has 10 radiopaque markers. There are two different types of introducers; percutaneous or endoscopic. They consists of an Inner Catheter, Outer Sheath, Hub, Y-connector, Tip and Pusher. All of the components of the introducers are supplied sterile in a disposable package. The Percutaneous type introducer is used when the site is accessed percutaneously and requires a guidewire (not included) to be advanced across the targeted stricture under fluoroscopy. The Endoscopic type introducer is for use in endoscopic procedures where the stent and introducer are inserted through the channel of an endoscope. The usable lengths of Percutaneous type introducer is 50cm and Endoscopic type introducer 180cm. Other information: The package is sterilized using Ethylene oxide. The diameter of compatible guide wire is 0.035 inch (0.89mm). Do not use if package is damaged. Do not reuse or resterilize.
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 20 |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou | Zhejiang | Repacker / relabeller | 19 |
| Dongguan TT Medical, Inc. | Dongguan | Guangdong | Manufacturer | 4 |
| LEO Medical Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Taewoongmedical.co., Ltd. |
|---|---|
| FDA product code | FGE |
| Device type | Stents, Drains And Dilators For The Biliary Ducts |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5010 |
| 510(k) | K073667 |
| Record published | 2015-09-10 |
| Record revised | 2026-04-07 (version 6) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | expiry date, manufacturing date, serial number |
| Sizes | Length 40 to 120 mm; outer diameter 8 to 10 mm; catheter gauge 8 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TD0806 | Length 60 mm | In distribution |
| BD1010 | Length 100 mm | In distribution |
| TD0809 | Length 90 mm | In distribution |
| BD0804 | Length 40 mm | In distribution |
| TD0808 | Length 80 mm | In distribution |
| TD1004 | Length 40 mm | In distribution |
| BD1012 | Length 120 mm | In distribution |
| TD0804 | Length 40 mm | In distribution |
| TD0805 | Length 50 mm | In distribution |
| BD0809 | Length 90 mm | In distribution |
| BD1005 | Length 50 mm | In distribution |
| TD0810 | Length 100 mm | In distribution |
| TD1005 | Length 50 mm | In distribution |
| BD0806 | Length 60 mm | In distribution |
| BD0808 | Length 80 mm | In distribution |
| TD1010 | Length 100 mm | In distribution |
| BD1008 | Length 80 mm | In distribution |
| BD1006 | Length 60 mm | In distribution |
| BD1007 | Length 70 mm | In distribution |
| TD1006 | Length 60 mm | In distribution |
| BD0807 | Length 70 mm | In distribution |
| TD1007 | Length 70 mm | In distribution |
| TD1008 | Length 80 mm | In distribution |
| BD0805 | Length 50 mm | In distribution |
| BD1009 | Length 90 mm | In distribution |
| TD1012 | Length 120 mm | In distribution |
| BD0810 | Length 100 mm | In distribution |
| BD0812 | Length 120 mm | In distribution |
| TD1009 | Length 90 mm | In distribution |
| BD1004 | Length 40 mm | In distribution |
| TD0812 | Length 120 mm | In distribution |
| TD0807 | Length 70 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Zimmon | Cook Ireland Ltd | 213 |
| Single Use Biliary Drainage Stent V | Olympus Medical Systems Corp. | 181 |
| Mustang™ | Boston Scientific Corporation | 167 |
| Geenen | Cook Ireland Ltd | 158 |
| Cotton-Leung | Cook Ireland Ltd | 144 |
| Advanix™ Pancreatic Stent | Boston Scientific Corporation | 135 |
| Single Use Biliary Stent V | Olympus Medical Systems Corp. | 106 |
| Single-use Balloon Dilatation Catheter | LEO Medical Co., Ltd. | 102 |
| Biliary Plastic Stent Set | Micro-Tech (Nanjing) Co., Ltd. | 90 |
| Biliary Plastic Stent | Micro-Tech (Nanjing) Co., Ltd. | 90 |
| M-Drain | Mermaid Medical A/S | 86 |
| Advanix™ Biliary | Boston Scientific Corporation | 84 |
Showing 12 of 212. All products under Stents, Drains And Dilators For The Biliary Ducts
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.