Single Use Biliary Balloon Dilator
The Single Use Biliary Balloon Dilator is a catheter used with Olympus endoscopes to dilate strictures in the biliary tree or major duodenal papilla. Its distal balloon expands with…
The Single Use Biliary Balloon Dilator is a catheter used with Olympus endoscopes to dilate strictures in the biliary tree or major duodenal papilla. Its distal balloon expands with injected fluid to apply radial force against the narrowed duct segment.
The device has a triple-lumen catheter design and a balloon mounted at its distal end. Inflation fluid enters through the balloon lumen hub after the balloon is positioned at the stricture. The dilator is intended for a single endoscopic procedure.
Endoscopic Placement
The catheter is used in conjunction with the endoscope during biliary dilation rather than as a general vascular angioplasty catheter. Its working assembly must permit insertion and withdrawal through the scope, guidewire movement, balloon inflation and subsequent deflation before removal.
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 | Olympus Medical Systems Corp., Japan |
|---|---|
| FDA product code | FGE |
| Device type | Stents, Drains And Dilators For The Biliary Ducts |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5010 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K143303 |
| Record published | 2017-09-05 |
| Record revised | 2024-12-23 (version 9) |
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 |
| Distribution end date | 2022-08-19 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BD-210N-0440 | In distribution | |
| BD-210N-0420 | In distribution | |
| BD-210N-0620 | In distribution | |
| BD-210N-0640 | In distribution | |
| BD-210N-0830 | In distribution | |
| BD-210N-0620 | Withdrawn | |
| BD-210N-0420 | Withdrawn | |
| BD-210N-0830 | Withdrawn | |
| BD-210N-0440 | Withdrawn | |
| BD-210N-0640 | Withdrawn |
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 |
|---|---|
| K250409 | 2025-10-21 |
| K143303 | 2015-02-27 |
| K103478 | 2011-02-24 |
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.