Biliary drains
BONASTENT Biliary
A non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency; it is not intended for vascular implantation. It may be a mesh structure or a continuous tube and is made entirely of metal [e.g., high-grade stainless steel, cobalt-chrome (Co-Cr), nickel-titanium alloy (Nitinol)]. It may be expandable in situ (e.g., with a balloon catheter or self-expands) and disposable devices intended to assist implantation may be included.
Find similar biliary stents
Where to buy BONASTENT Biliary
We do not have contact details for Sewoon Medical Co., Ltd. yet. Send a request and we will route it to the right person for your country.
BONASTENT Biliary 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 |
|---|---|---|---|
| BB-080518 | — | MR Conditional | Available |
| BB-080618 | — | MR Conditional | Available |
| BB-080718 | — | MR Conditional | Available |
| BB-080818 | — | MR Conditional | Available |
| BB-080918 | — | MR Conditional | Available |
| BB-081018 | — | MR Conditional | Available |
| BB-100518 | — | MR Conditional | Available |
| BB-100618 | — | MR Conditional | Available |
| BB-100718 | — | MR Conditional | Available |
| BB-100818 | — | MR Conditional | Available |
| BB-100918 | — | MR Conditional | Available |
| BB-101018 | — | MR Conditional | Available |
FDA clearances
- 510(k) K140760 June 2014
Procedures that use biliary drains
Frequently asked questions
What is BONASTENT Biliary used for?
A non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency; it is not intended for vascular implantation. It may be a mesh structure or a continuous tube and is made entirely of metal [e.g., high-grade stainless steel, cobalt-chrome (Co-Cr), nickel-titanium alloy (Nitinol)]. It may be expandable in situ (e.g., with a balloon catheter or self-expands) and disposable devices intended to assist implantation may be included.
Who makes BONASTENT Biliary?
BONASTENT Biliary is made by Sewoon Medical Co., Ltd.. It is listed under biliary drainage catheters in our device library.
What sizes does BONASTENT Biliary come in?
The FDA device database does not list sizes for BONASTENT Biliary. Check the instructions for use or ask a Sewoon Medical Co., Ltd. representative.
Is BONASTENT Biliary MRI safe?
The FDA device database lists BONASTENT Biliary as MR Conditional. Always follow the specific MRI conditions in the labeling.
Is BONASTENT Biliary FDA cleared?
BONASTENT Biliary is covered by FDA submission K140760.
How do I contact a Sewoon Medical Co., Ltd. sales representative?
Sewoon Medical Co., Ltd. has not listed representatives on LA Vascular yet. Visit the Sewoon 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.