Biliary drains
Dilation Balloon Catheter
by Micro-Tech (Nanjing) Co., Ltd.
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.
Dilation Balloon 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 |
|---|---|---|---|
| EC01000 | Balloon Diameter 4 mm; Balloon Length 20 mm | Not stated | Available |
| EC01001 | Balloon Diameter 6 mm; Balloon Length 20 mm | Not stated | Available |
| EC01002 | Balloon Diameter 8 mm; Balloon Length 20 mm | Not stated | Available |
| EC01003 | Balloon Diameter 4 mm; Balloon Length 30 mm | Not stated | Available |
| EC01004 | Balloon Diameter 6 mm; Balloon Length 30 mm | Not stated | Available |
| EC01005 | Balloon Diameter 8 mm; Balloon Length 30 mm | Not stated | Available |
| EC01006 | Balloon Diameter 4 mm; Balloon Length 40 mm | Not stated | Available |
| EC01007 | Balloon Diameter 6 mm; Balloon Length 40 mm | Not stated | Available |
| EC01008 | Balloon Diameter 8 mm; Balloon Length 40 mm | Not stated | Available |
FDA clearances
- 510(k) K253832 April 2026
Procedures that use biliary drains
Frequently asked questions
What is Dilation Balloon 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 Dilation Balloon Catheter?
Dilation Balloon Catheter is made by Micro-Tech (Nanjing) Co., Ltd.. It is listed under biliary drainage catheters in our device library.
What sizes does Dilation Balloon Catheter come in?
Sizes listed for Dilation Balloon Catheter: Balloon Diameter: 4–8 mm; Balloon Length: 20–40 mm. Confirm availability with the manufacturer's instructions for use.
Is Dilation Balloon Catheter MRI safe?
The FDA device database entry for Dilation Balloon Catheter does not state its MRI safety status. Check the labeling before MRI.
Is Dilation Balloon Catheter FDA cleared?
Dilation Balloon Catheter is covered by FDA submission K253832.
How do I contact a Micro-Tech (Nanjing) Co., Ltd. sales representative?
Micro-Tech (Nanjing) Co., Ltd. has not listed representatives on LA Vascular yet. Visit the Micro-Tech (Nanjing) 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.