Disposable Balloon Catheter
Disposable Balloon Catheters B5-2Q and B7-2LA are used with Olympus endoscopes to retrieve stones or inject contrast into the biliary or pancreatic tract. The assembly includes an…
Disposable Balloon Catheters B5-2Q and B7-2LA are used with Olympus endoscopes to retrieve stones or inject contrast into the biliary or pancreatic tract. The assembly includes an inflatable balloon, tube, branch, injection port, air-feeding port and stopcock.
The deflated catheter passes through the endoscope channel to the target area. Air delivered through the feeding port inflates the balloon for stone retrieval or contrast injection through the separate injection port. After the procedure, the balloon is deflated before catheter removal.
Model Dimensions
B5-2Q has a 1950 mm working length and an 11 mm inflated balloon diameter; B7-2LA has a 3500 mm working length and a 13 mm balloon diameter. The balloons contain natural-rubber latex. These catheters are supplied ethylene-oxide sterilized 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 | 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) | K250409 |
| Record published | 2024-03-25 |
| Record revised | 2025-11-24 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B5-2Q | In distribution | |
| B7-2LA | In distribution | |
| B7-2Q | In distribution | |
| B7-2LA | In distribution | |
| B7-2Q | In distribution | |
| B5-2Q | In distribution | |
| B7-2Q | In distribution | |
| B7-2LA | In distribution | |
| B5-2Q | 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 |
|---|---|
| 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.