Single-Use Balloon Dilatation Catheter
The Single-use Balloon Dilatation Catheter is intended for endoscopic dilation of gastrointestinal strictures in adults and adolescents. It is also indicated in adults for dilation of the…
The Single-use Balloon Dilatation Catheter is intended for endoscopic dilation of gastrointestinal strictures in adults and adolescents. It is also indicated in adults for dilation of the sphincter of Oddi with or without prior sphincterotomy. A distal balloon expands to dilate the narrowed region.
The range includes rapid-exchange, over-the-wire and over-the-wire models preloaded with stainless-steel guidewire and a wire-locking component. In the over-the-wire designs, the wire passes through the catheter lumen; the rapid-exchange design instead uses an exchange port on the shaft.
Working Dimensions
Catheter effective lengths are 180 or 240 cm, with balloon lengths of 30, 55 or 80 mm. Balloon size groups provide three diameters per group, extending from 6, 7 and 8 mm in the smallest group to 18, 19 and 20 mm in the largest.
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 | LEO Medical 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 | Manufacturer |
| 510(k) | K241888 |
| Record published | 2026-01-04 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KZ1030E0 | In distribution | |
| KZ1055G0 | In distribution | |
| KZ0655H3 | In distribution | |
| KZ1580H1 | In distribution | |
| KZ0855H0 | In distribution | |
| KZ1555G1 | In distribution | |
| KZ1530E1 | In distribution | |
| KZ0855H3 | In distribution | |
| KZ1855G0 | In distribution | |
| KZ1030H0 | In distribution | |
| KZ1080H1 | In distribution | |
| KZ1555G3 | In distribution | |
| KZ0680F3 | In distribution | |
| KZ1880H3 | In distribution | |
| KZ1280F0 | In distribution | |
| KZ1555H1 | In distribution | |
| KZ1855G1 | In distribution | |
| KZ1280F3 | In distribution | |
| KZ0680F0 | In distribution | |
| KZ1530H3 | In distribution | |
| KZ1255H3 | In distribution | |
| KZ0680H0 | In distribution | |
| KZ0830H0 | In distribution | |
| KZ0880H3 | In distribution | |
| KZ1855H3 | In distribution | |
| KZ1055H3 | In distribution | |
| KZ0630E0 | In distribution | |
| KZ1880H0 | In distribution | |
| KZ1580F0 | In distribution | |
| KZ1055G3 | In distribution | |
| KZ1055H1 | In distribution | |
| KZ0880H0 | In distribution | |
| KZ0680F1 | In distribution | |
| KZ0880F0 | In distribution | |
| KZ1030E3 | In distribution | |
| KZ0855G0 | In distribution | |
| KZ0830H1 | In distribution | |
| KZ1230E0 | In distribution | |
| KZ1055G1 | In distribution | |
| KZ1255H1 | In distribution | |
| KZ0880F3 | In distribution | |
| KZ1030E1 | In distribution | |
| KZ1855G3 | In distribution | |
| KZ0630E3 | In distribution | |
| KZ1580H3 | In distribution | |
| KZ1880H1 | In distribution | |
| KZ1855H0 | In distribution | |
| KZ1080H3 | In distribution | |
| KZ0655H0 | In distribution | |
| KZ0855G3 | In distribution | |
| KZ0680H1 | In distribution | |
| KZ1280H3 | In distribution | |
| KZ1230H1 | In distribution | |
| KZ1555H0 | In distribution | |
| KZ1080F1 | In distribution | |
| KZ1055H0 | In distribution | |
| KZ1030H3 | In distribution | |
| KZ1880F3 | In distribution | |
| KZ1530E3 | In distribution | |
| KZ0830H3 | In distribution | |
| KZ0655G1 | In distribution | |
| KZ0630H3 | In distribution | |
| KZ1255G3 | In distribution | |
| KZ1280F1 | In distribution | |
| KZ1580F1 | In distribution | |
| KZ0680H3 | In distribution | |
| KZ1855H1 | In distribution | |
| KZ0855H1 | In distribution | |
| KZ1880F0 | In distribution | |
| KZ1530E0 | In distribution | |
| KZ1580F3 | In distribution | |
| KZ1530H0 | In distribution | |
| KZ0630E1 | In distribution | |
| KZ1230H0 | In distribution | |
| KZ0655G0 | In distribution | |
| KZ1280H0 | In distribution | |
| KZ0880F1 | In distribution | |
| KZ1255G1 | In distribution | |
| KZ0830E1 | In distribution | |
| KZ1555G0 | In distribution | |
| KZ1580H0 | In distribution | |
| KZ1080F3 | In distribution | |
| KZ1255H0 | In distribution | |
| KZ0855G1 | In distribution | |
| KZ1230H3 | In distribution | |
| KZ1555H3 | In distribution | |
| KZ1080F0 | In distribution | |
| KZ1230E3 | In distribution | |
| KZ0830E0 | In distribution | |
| KZ1880F1 | In distribution | |
| KZ0655H1 | In distribution | |
| KZ1030H1 | In distribution | |
| KZ0830E3 | In distribution | |
| KZ1530H1 | In distribution | |
| KZ0880H1 | In distribution | |
| KZ1255G0 | In distribution | |
| KZ0630H1 | In distribution | |
| KZ0655G3 | In distribution | |
| KZ1280H1 | In distribution | |
| KZ0630H0 | In distribution | |
| KZ1080H0 | In distribution | |
| KZ1230E1 | 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 |
| 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 |
| Visi-Pro™ | Covidien LP | 81 |
Showing 12 of 212. All products under Stents, Drains And Dilators For The Biliary Ducts
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241888 | 2024-12-20 |
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.