Biliary drains
Single-use Balloon Dilatation Catheter
A long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, may be of the fixed-wire or wire-guided type, and is not coated with a drug/pharmaceutical. This is a single-use device.
Find similar drainage catheters
Where to buy Single-use Balloon Dilatation Catheter
We do not have contact details for Leo Medical Co., Ltd. yet. Send a request and we will route it to the right person for your country.
Single-use Balloon Dilatation Catheter models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| KZ0630E0 | — | Not stated | Available |
| KZ0630E1 | — | Not stated | Available |
| KZ0630E3 | — | Not stated | Available |
| KZ0630H0 | — | Not stated | Available |
| KZ0630H1 | — | Not stated | Available |
| KZ0630H3 | — | Not stated | Available |
| KZ0655G0 | — | Not stated | Available |
| KZ0655G1 | — | Not stated | Available |
| KZ0655G3 | — | Not stated | Available |
| KZ0655H0 | — | Not stated | Available |
| KZ0655H1 | — | Not stated | Available |
| KZ0655H3 | — | Not stated | Available |
| KZ0680F0 | — | Not stated | Available |
| KZ0680F1 | — | Not stated | Available |
| KZ0680F3 | — | Not stated | Available |
| KZ0680H0 | — | Not stated | Available |
| KZ0680H1 | — | Not stated | Available |
| KZ0680H3 | — | Not stated | Available |
| KZ0830E0 | — | Not stated | Available |
| KZ0830E1 | — | Not stated | Available |
| KZ0830E3 | — | Not stated | Available |
| KZ0830H0 | — | Not stated | Available |
| KZ0830H1 | — | Not stated | Available |
| KZ0830H3 | — | Not stated | Available |
| KZ0855G0 | — | Not stated | Available |
| KZ0855G1 | — | Not stated | Available |
| KZ0855G3 | — | Not stated | Available |
| KZ0855H0 | — | Not stated | Available |
| KZ0855H1 | — | Not stated | Available |
| KZ0855H3 | — | Not stated | Available |
| KZ0880F0 | — | Not stated | Available |
| KZ0880F1 | — | Not stated | Available |
| KZ0880F3 | — | Not stated | Available |
| KZ0880H0 | — | Not stated | Available |
| KZ0880H1 | — | Not stated | Available |
| KZ0880H3 | — | Not stated | Available |
| KZ1030E0 | — | Not stated | Available |
| KZ1030E1 | — | Not stated | Available |
| KZ1030E3 | — | Not stated | Available |
| KZ1030H0 | — | Not stated | Available |
| KZ1030H1 | — | Not stated | Available |
| KZ1030H3 | — | Not stated | Available |
| KZ1055G0 | — | Not stated | Available |
| KZ1055G1 | — | Not stated | Available |
| KZ1055G3 | — | Not stated | Available |
| KZ1055H0 | — | Not stated | Available |
| KZ1055H1 | — | Not stated | Available |
| KZ1055H3 | — | Not stated | Available |
| KZ1080F0 | — | Not stated | Available |
| KZ1080F1 | — | Not stated | Available |
| KZ1080F3 | — | Not stated | Available |
| KZ1080H0 | — | Not stated | Available |
| KZ1080H1 | — | Not stated | Available |
| KZ1080H3 | — | Not stated | Available |
| KZ1230E0 | — | Not stated | Available |
| KZ1230E1 | — | Not stated | Available |
| KZ1230E3 | — | Not stated | Available |
| KZ1230H0 | — | Not stated | Available |
| KZ1230H1 | — | Not stated | Available |
| KZ1230H3 | — | Not stated | Available |
| KZ1255G0 | — | Not stated | Available |
| KZ1255G1 | — | Not stated | Available |
| KZ1255G3 | — | Not stated | Available |
| KZ1255H0 | — | Not stated | Available |
| KZ1255H1 | — | Not stated | Available |
| KZ1255H3 | — | Not stated | Available |
| KZ1280F0 | — | Not stated | Available |
| KZ1280F1 | — | Not stated | Available |
| KZ1280F3 | — | Not stated | Available |
| KZ1280H0 | — | Not stated | Available |
| KZ1280H1 | — | Not stated | Available |
| KZ1280H3 | — | Not stated | Available |
| KZ1530E0 | — | Not stated | Available |
| KZ1530E1 | — | Not stated | Available |
| KZ1530E3 | — | Not stated | Available |
| KZ1530H0 | — | Not stated | Available |
| KZ1530H1 | — | Not stated | Available |
| KZ1530H3 | — | Not stated | Available |
| KZ1555G0 | — | Not stated | Available |
| KZ1555G1 | — | Not stated | Available |
| KZ1555G3 | — | Not stated | Available |
| KZ1555H0 | — | Not stated | Available |
| KZ1555H1 | — | Not stated | Available |
| KZ1555H3 | — | Not stated | Available |
| KZ1580F0 | — | Not stated | Available |
| KZ1580F1 | — | Not stated | Available |
| KZ1580F3 | — | Not stated | Available |
| KZ1580H0 | — | Not stated | Available |
| KZ1580H1 | — | Not stated | Available |
| KZ1580H3 | — | Not stated | Available |
| KZ1855G0 | — | Not stated | Available |
| KZ1855G1 | — | Not stated | Available |
| KZ1855G3 | — | Not stated | Available |
| KZ1855H0 | — | Not stated | Available |
| KZ1855H1 | — | Not stated | Available |
| KZ1855H3 | — | Not stated | Available |
| KZ1880F0 | — | Not stated | Available |
| KZ1880F1 | — | Not stated | Available |
| KZ1880F3 | — | Not stated | Available |
| KZ1880H0 | — | Not stated | Available |
| KZ1880H1 | — | Not stated | Available |
| KZ1880H3 | — | Not stated | Available |
FDA clearances
- 510(k) K241888 December 2024
Procedures that use biliary drains
Frequently asked questions
What is Single-use Balloon Dilatation Catheter used for?
A long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, may be of the fixed-wire or wire-guided type, and is not coated with a drug/pharmaceutical. This is a single-use device.
Who makes Single-use Balloon Dilatation Catheter?
Single-use Balloon Dilatation Catheter is made by Leo Medical Co., Ltd.. It is listed under biliary drainage catheters in our device library.
What sizes does Single-use Balloon Dilatation Catheter come in?
The FDA device database does not list sizes for Single-use Balloon Dilatation Catheter. Check the instructions for use or ask a Leo Medical Co., Ltd. representative.
Is Single-use Balloon Dilatation Catheter MRI safe?
The FDA device database entry for Single-use Balloon Dilatation Catheter does not state its MRI safety status. Check the labeling before MRI.
Is Single-use Balloon Dilatation Catheter FDA cleared?
Single-use Balloon Dilatation Catheter is covered by FDA submission K241888.
How do I contact a Leo Medical Co., Ltd. sales representative?
Leo Medical Co., Ltd. has not listed representatives on LA Vascular yet. Visit the Leo Medical Co., Ltd. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.