Dilation Balloon Catheter
Working Length 2900mm, Maximum Outer Diameter of Insertion Part less than 1.8mm, Balloon Length 40mm, Balloon OD 4mm, Rated Pressure 6atm, Burst Pressure 10atm, Compatible Guidewire no more…
Working Length 2900mm, Maximum Outer Diameter of Insertion Part less than 1.8mm, Balloon Length 40mm, Balloon OD 4mm, Rated Pressure 6atm, Burst Pressure 10atm, Compatible Guidewire no more than 0.021inch, Working Channel greater than or equal to 1.8mm
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) | K253832 |
| Record published | 2026-06-30 |
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 | Box, case of 10 |
| Sizes | Balloon diameter 4 to 8 mm; balloon length 20 to 40 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EC01006 | Balloon Diameter 4 mm | In distribution |
| EC01002 | Balloon Diameter 8 mm | In distribution |
| EC01004 | Balloon Diameter 6 mm | In distribution |
| EC01001 | Balloon Diameter 6 mm | In distribution |
| EC01005 | Balloon Diameter 8 mm | In distribution |
| EC01008 | Balloon Diameter 8 mm | In distribution |
| EC01007 | Balloon Diameter 6 mm | In distribution |
| EC01003 | Balloon Diameter 4 mm | In distribution |
| EC01000 | Balloon Diameter 4 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.