Sterile Biliary Stone Retrieval Balloon Catheter
The Sterile Biliary Stone Retrieval Balloon Catheter uses a distal balloon to sweep stones from the biliary tract during endoscopy. Its Pebax shaft contains separate lumens for balloon…
The Sterile Biliary Stone Retrieval Balloon Catheter uses a distal balloon to sweep stones from the biliary tract during endoscopy. Its Pebax shaft contains separate lumens for balloon inflation, a guidewire and contrast injection.
The balloon is natural latex. Predetermined syringe volumes inflate it to the selected diameter, and some balloon configurations can reach two or three sizes without exchanging the catheter.
Listed Item
Sterile Biliary Stone Retrieval Balloon Catheter with triple-lumen, Work diameter 15mm/18mm/21mm, Working Length 2000mm,
Wire and Imaging Features
The catheter accepts a 0.035 inch guidewire and has radiopaque bands at both ends of the balloon. Standard long-wire and separate short-wire configurations are available; the latter uses a side groove for wire separation. The catheter is supplied sterile 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) | K211021 |
| Record published | 2022-12-31 |
| Record revised | 2025-12-22 (version 4) |
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, manufacturing date |
| Packaging | Box, case of 10 |
| Sizes | Balloon diameter 9 to 21 mm; catheter working length 2000 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SRB-T-12/15-20-G | Balloon Diameter 12 mm | In distribution |
| SRB-T-9/12/15-20-B | Balloon Diameter 9 mm | In distribution |
| SRB-T-15/18/21-20-G | Balloon Diameter 15 mm | In distribution |
| SRB-T-18/21-20-G | Balloon Diameter 18 mm | In distribution |
| SRB-T-15/18/21-20 | Balloon Diameter 15 mm | In distribution |
| SRB-T-15/18-20 | Balloon Diameter 15 mm | In distribution |
| SRB-T-15/18-20-B | Balloon Diameter 15 mm | In distribution |
| SRB-T-12/15-20-B | Balloon Diameter 12 mm | In distribution |
| SRB-T-9/12-20 | Balloon Diameter 9 mm | In distribution |
| SRB-T-15/18/21-20-B | Balloon Diameter 15 mm | In distribution |
| SRB-T-9/12/15-20-G-B | Balloon Diameter 9 mm | In distribution |
| SRB-T-15/18-20-G | Balloon Diameter 15 mm | In distribution |
| SRB-T-9/12-20-B | Balloon Diameter 9 mm | In distribution |
| SRB-T-12/15/18-20-G | Balloon Diameter 12 mm | In distribution |
| SRB-T-12/15/18-20 | Balloon Diameter 12 mm | In distribution |
| SRB-T-15/18-20-G-B | Balloon Diameter 15 mm | In distribution |
| SRB-T-12/15-20-G-B | Balloon Diameter 12 mm | In distribution |
| SRB-T-18/21-20-G-B | Balloon Diameter 18 mm | In distribution |
| SRB-T-9/12-20-G | Balloon Diameter 9 mm | In distribution |
| SRB-T-18/21-20-B | Balloon Diameter 18 mm | In distribution |
| SRB-T-12/15/18-20-B | Balloon Diameter 12 mm | In distribution |
| SRB-T-15/18/21-20-G-B | Balloon Diameter 15 mm | In distribution |
| SRB-T-9/12-20-G-B | Balloon Diameter 9 mm | In distribution |
| SRB-T-18/21-20 | Balloon Diameter 18 mm | In distribution |
| SRB-T-9/12/15-20 | Balloon Diameter 9 mm | In distribution |
| SRB-T-9/12/15-20-G | Balloon Diameter 9 mm | In distribution |
| SRB-T-12/15-20 | Balloon Diameter 12 mm | In distribution |
| SRB-T-12/15/18-20-G-B | Balloon Diameter 12 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.