Reliant(TM) Multistage Dilatation Balloon Catheter
Reliant Multistage Dilatation Balloon Catheter dilates gastrointestinal strictures endoscopically in adults and adolescents. Its balloon reaches three progressively larger diameters through…
Reliant Multistage Dilatation Balloon Catheter dilates gastrointestinal strictures endoscopically in adults and adolescents. Its balloon reaches three progressively larger diameters through controlled radial expansion, with the applicable sizes printed on the package and hub.
The catheter passes through endoscope working channels of at least 2.8 mm and accepts a 0.035-inch guidewire. A guidewire is preloaded and secured by a locking device on the guidewire hub.
Listed Item
the balloon diameter is 8-9-10mm,the balloon length is 55mm,the catheter diameter is 7 Fr., and the working length is 2300mm,with stainless steel guide wire
Size and Supply
Working lengths are 1,800 or 2,300 mm, with balloon lengths of 30, 55 or 80 mm. Diameter groups span from 6/7/8 mm to 18/19/20 mm. Each catheter is supplied sterile in an individual pouch for single use.
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 | Micro-Tech (Nanjing) Co., Ltd., China |
|---|---|
| FDA product code | FGE |
| Device type | Stents, Drains And Dilators For The Biliary Ducts |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5010 |
| Establishment | Contract manufacturer, Contract steriliser, Manufacturer |
| 510(k) | K180418 |
| Record published | 2016-02-29 |
| Record revised | 2025-12-02 (version 8) |
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, manufacturing date |
| Packaging | Case |
| Sizes | Balloon length 55 to 80 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MBD-AL-BA-2 | Balloon Length 80 mm | In distribution |
| MBD-BM-BB-2 | Balloon Length 55 mm | In distribution |
| MBD-AM-BB-2 | Balloon Length 55 mm | In distribution |
| MBD-AM-BB-2 | Balloon Length 55 mm | In distribution |
| MBD-AM-BA-2 | Balloon Length 55 mm | In distribution |
| MBD-AL-BA-2 | Balloon Length 80 mm | In distribution |
| MBD-AM-BA-2 | Balloon Length 55 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K230127 | 2023-09-06 |
| K211021 | 2022-05-06 |
| K180418 | 2018-10-15 |
| K162226 | 2017-01-25 |
| K151671 | 2015-10-16 |
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.