Retrieval Balloon Short-Wire Compatible
Retrieval Balloon short-wire compatible is an endoscopic catheter for removing biliary stones or injecting contrast while the balloon occludes the duct. It is a sterile, single-use device…
Retrieval Balloon short-wire compatible is an endoscopic catheter for removing biliary stones or injecting contrast while the balloon occludes the duct. It is a sterile, single-use device with a short-wire design for 2.6 m guidewires.
A C-shaped sidewall groove allows the guidewire to separate from the catheter during exchange while a locking device maintains wire access. The catheter has three lumens for inflation, a 0.035 inch guidewire and contrast medium.
Listed Item
Retrieval Balloon / short-wire compatible; Preloaded guidewire, Have guidewire port, Balloon Work diameter 12/15mm; Working Length 2000mm; Above injection port.; Above injection port
Balloon Configurations
A natural-latex balloon on a Pebax catheter inflates to two or three selectable diameters using premeasured syringes. Radiopaque bands mark its proximal and distal ends; contrast injection is available in proximal or distal configurations.
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 | 2025-12-03 (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 | Catheter working length 2000 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RSRB-P-9/12/15-20-B | Catheter Working Length 2000 mm | In distribution |
| RSRB-P-9/12-20 | Catheter Working Length 2000 mm | In distribution |
| RSRB-P-15/18/21-20-G | Catheter Working Length 2000 mm | In distribution |
| RSRB-P-12/15/18-20-G-B | Catheter Working Length 2000 mm | In distribution |
| RSRB-P-12/15-20-G-B | Catheter Working Length 2000 mm | In distribution |
| RSRB-T-12/15/18-20 | Catheter Working Length 2000 mm | In distribution |
| RSRB-P-18/21-20-G-B | Catheter Working Length 2000 mm | In distribution |
| RSRB-T-18/21-20 | Catheter Working Length 2000 mm | In distribution |
| RSRB-P-15/18-20-G | Catheter Working Length 2000 mm | In distribution |
| RSRB-T-12/15-20-B | Catheter Working Length 2000 mm | In distribution |
| RSRB-P-15/18/21-20-G-B | Catheter Working Length 2000 mm | In distribution |
| RSRB-T-15/18/21-20-B | Catheter Working Length 2000 mm | In distribution |
| RSRB-T-9/12/15-20-B | Catheter Working Length 2000 mm | In distribution |
| RSRB-T-12/15/18-20-B | Catheter Working Length 2000 mm | In distribution |
| RSRB-T-9/12/15-20 | Catheter Working Length 2000 mm | In distribution |
| RSRB-P-9/12-20-G-B | Catheter Working Length 2000 mm | In distribution |
| RSRB-P-15/18/21-20 | Catheter Working Length 2000 mm | In distribution |
| RSRB-P-15/18-20-G-B | Catheter Working Length 2000 mm | In distribution |
| RSRB-P-12/15-20-G | Catheter Working Length 2000 mm | In distribution |
| RSRB-T-15/18/21-20 | Catheter Working Length 2000 mm | In distribution |
| RSRB-P-9/12/15-20 | Catheter Working Length 2000 mm | In distribution |
| RSRB-T-9/12-20 | Catheter Working Length 2000 mm | In distribution |
| RSRB-P-12/15/18-20-G | Catheter Working Length 2000 mm | In distribution |
| RSRB-T-15/18-20-B | Catheter Working Length 2000 mm | In distribution |
| RSRB-P-9/12/15-20-G-B | Catheter Working Length 2000 mm | In distribution |
| RSRB-P-12/15-20 | Catheter Working Length 2000 mm | In distribution |
| RSRB-T-12/15-20 | Catheter Working Length 2000 mm | In distribution |
| RSRB-P-15/18/21-20-B | Catheter Working Length 2000 mm | In distribution |
| RSRB-P-12/15-20-B | Catheter Working Length 2000 mm | In distribution |
| RSRB-P-18/21-20 | Catheter Working Length 2000 mm | In distribution |
| RSRB-T-9/12-20-B | Catheter Working Length 2000 mm | In distribution |
| RSRB-P-18/21-20-B | Catheter Working Length 2000 mm | In distribution |
| RSRB-P-9/12/15-20-G | Catheter Working Length 2000 mm | In distribution |
| RSRB-P-12/15/18-20 | Catheter Working Length 2000 mm | In distribution |
| RSRB-P-9/12-20-G | Catheter Working Length 2000 mm | In distribution |
| RSRB-T-18/21-20-B | Catheter Working Length 2000 mm | In distribution |
| RSRB-P-15/18-20-B | Catheter Working Length 2000 mm | In distribution |
| RSRB-P-15/18-20 | Catheter Working Length 2000 mm | In distribution |
| RSRB-P-12/15/18-20-B | Catheter Working Length 2000 mm | In distribution |
| RSRB-T-15/18-20 | Catheter Working Length 2000 mm | In distribution |
| RSRB-P-18/21-20-G | Catheter Working Length 2000 mm | In distribution |
| RSRB-P-9/12-20-B | Catheter Working Length 2000 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.