Biliary drains
Disposable Sure-Flex Biliary 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 Disposable Sure-Flex Biliary Balloon Dilatation Catheter
We do not have contact details for Telemed Systems yet. Send a request and we will route it to the right person for your country.
Disposable Sure-Flex Biliary 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 |
|---|---|---|---|
| 1342 | Length 2 cm; Length 180 cm | Not stated | Available |
| 1344 | Length 4 cm; Length 180 cm | Not stated | Available |
| 1346 | Length 8 cm; Length 180 cm | Not stated | Available |
FDA clearances
- 510(k) K901432 June 1990
Procedures that use biliary drains
Frequently asked questions
What is Disposable Sure-Flex Biliary 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 Disposable Sure-Flex Biliary Balloon Dilatation Catheter?
Disposable Sure-Flex Biliary Balloon Dilatation Catheter is made by Telemed Systems. It is listed under biliary drainage catheters in our device library.
What sizes does Disposable Sure-Flex Biliary Balloon Dilatation Catheter come in?
Sizes listed for Disposable Sure-Flex Biliary Balloon Dilatation Catheter: Length: 2–180 cm. Confirm availability with the manufacturer's instructions for use.
Is Disposable Sure-Flex Biliary Balloon Dilatation Catheter MRI safe?
The FDA device database entry for Disposable Sure-Flex Biliary Balloon Dilatation Catheter does not state its MRI safety status. Check the labeling before MRI.
Is Disposable Sure-Flex Biliary Balloon Dilatation Catheter FDA cleared?
Disposable Sure-Flex Biliary Balloon Dilatation Catheter is covered by FDA submission K901432.
How do I contact a Telemed Systems sales representative?
Telemed Systems has not listed representatives on LA Vascular yet. Visit the Telemed Systems 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.