Biliary drains
Single Use Biliary Balloon Dilator
by Olympus Medical Systems Corp.
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 Biliary Balloon Dilator
We do not have contact details for Olympus Medical Systems Corp. yet. Send a request and we will route it to the right person for your country.
Single Use Biliary Balloon Dilator 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 |
|---|---|---|---|
| BD-210N-0420 | — | Not stated | Available |
| BD-210N-0420 | — | Not stated | Available |
| BD-210N-0440 | — | Not stated | Available |
| BD-210N-0440 | — | Not stated | Available |
| BD-210N-0620 | — | Not stated | Available |
| BD-210N-0620 | — | Not stated | Available |
| BD-210N-0640 | — | Not stated | Available |
| BD-210N-0640 | — | Not stated | Available |
| BD-210N-0830 | — | Not stated | Available |
| BD-210N-0830 | — | Not stated | Available |
FDA clearances
- 510(k) K143303 February 2015
Procedures that use biliary drains
Frequently asked questions
What is Single Use Biliary Balloon Dilator 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 Biliary Balloon Dilator?
Single Use Biliary Balloon Dilator is made by Olympus Medical Systems Corp.. It is listed under biliary drainage catheters in our device library.
What sizes does Single Use Biliary Balloon Dilator come in?
The FDA device database does not list sizes for Single Use Biliary Balloon Dilator. Check the instructions for use or ask a Olympus Medical Systems Corp. representative.
Is Single Use Biliary Balloon Dilator MRI safe?
The FDA device database entry for Single Use Biliary Balloon Dilator does not state its MRI safety status. Check the labeling before MRI.
Is Single Use Biliary Balloon Dilator FDA cleared?
Single Use Biliary Balloon Dilator is covered by FDA submission K143303.
How do I contact a Olympus Medical Systems Corp. sales representative?
Olympus Medical Systems Corp. has not listed representatives on LA Vascular yet. Visit the Olympus Medical Systems Corp. 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.