Niti-S Biliary Speed D Stent
The Niti-S Biliary Speed D Stent consists of an implantable metallic stent and a disposable, flexible Stent Delivery System for placement of the stent.
6manufacturers in China registered for this device type
16catalogue numbers in this listing
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) | K223626 |
| Record published | 2023-06-01 |
| Record revised | 2026-04-07 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | expiry date, manufacturing date, serial number |
| Sizes | Stent diameter 8 to 10 mm; stent length 40 to 120 mm; catheter working length 180 cm; crossing profile 8.5 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BDM1006 | Stent Diameter 10 mm | In distribution |
| BDM1009 | Stent Diameter 10 mm | In distribution |
| BDM0809 | Stent Diameter 8 mm | In distribution |
| BDM1008 | Stent Diameter 10 mm | In distribution |
| BDM0804 | Stent Diameter 8 mm | In distribution |
| BDM1010 | Stent Diameter 10 mm | In distribution |
| BDM1007 | Stent Diameter 10 mm | In distribution |
| BDM0807 | Stent Diameter 8 mm | In distribution |
| BDM1004 | Stent Diameter 10 mm | In distribution |
| BDM0805 | Stent Diameter 8 mm | In distribution |
| BDM0806 | Stent Diameter 8 mm | In distribution |
| BDM0808 | Stent Diameter 8 mm | In distribution |
| BDM1012 | Stent Diameter 10 mm | In distribution |
| BDM1005 | Stent Diameter 10 mm | In distribution |
| BDM0812 | Stent Diameter 8 mm | In distribution |
| BDM0810 | Stent Diameter 8 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.