Biliary drains
Niti-S Biliary Stent
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.
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Where to buy Niti-S Biliary Stent
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Niti-S Biliary Stent 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 |
|---|---|---|---|
| BD0804 | Length 40 mm; Outer Diameter 8 mm; Catheter Gauge 8 Fr | MR Conditional | Available |
| BD0805 | Length 50 mm; Outer Diameter 8 mm; Catheter Gauge 8 Fr | MR Conditional | Available |
| BD0806 | Length 60 mm; Outer Diameter 8 mm; Catheter Gauge 8 Fr | MR Conditional | Available |
| BD0807 | Length 70 mm; Outer Diameter 8 mm; Catheter Gauge 8 Fr | MR Conditional | Available |
| BD0808 | Length 80 mm; Outer Diameter 8 mm; Catheter Gauge 8 Fr | MR Conditional | Available |
| BD0809 | Length 90 mm; Outer Diameter 8 mm; Catheter Gauge 8 Fr | MR Conditional | Available |
| BD0810 | Length 100 mm; Outer Diameter 8 mm; Catheter Gauge 8 Fr | MR Conditional | Available |
| BD0812 | Length 120 mm; Outer Diameter 8 mm; Catheter Gauge 8 Fr | MR Conditional | Available |
| BD1004 | Length 40 mm; Outer Diameter 10 mm; Catheter Gauge 8 Fr | MR Conditional | Available |
| BD1005 | Length 50 mm; Outer Diameter 10 mm; Catheter Gauge 8 Fr | MR Conditional | Available |
| BD1006 | Length 60 mm; Outer Diameter 10 mm; Catheter Gauge 8 Fr | MR Conditional | Available |
| BD1007 | Length 70 mm; Outer Diameter 10 mm; Catheter Gauge 8 Fr | MR Conditional | Available |
| BD1008 | Length 80 mm; Outer Diameter 10 mm; Catheter Gauge 8 Fr | MR Conditional | Available |
| BD1009 | Length 90 mm; Outer Diameter 10 mm; Catheter Gauge 8 Fr | MR Conditional | Available |
| BD1010 | Length 100 mm; Outer Diameter 10 mm; Catheter Gauge 8 Fr | MR Conditional | Available |
| BD1012 | Length 120 mm; Outer Diameter 10 mm; Catheter Gauge 8 Fr | MR Conditional | Available |
| TD0804 | Length 40 mm; Outer Diameter 8 mm; Catheter Gauge 8 Fr | MR Conditional | Available |
| TD0805 | Length 50 mm; Outer Diameter 8 mm; Catheter Gauge 8 Fr | MR Conditional | Available |
| TD0806 | Length 60 mm; Outer Diameter 8 mm; Catheter Gauge 8 Fr | MR Conditional | Available |
| TD0807 | Length 70 mm; Outer Diameter 8 mm; Catheter Gauge 8 Fr | MR Conditional | Available |
| TD0808 | Length 80 mm; Outer Diameter 8 mm; Catheter Gauge 8 Fr | MR Conditional | Available |
| TD0809 | Length 90 mm; Outer Diameter 8 mm; Catheter Gauge 8 Fr | MR Conditional | Available |
| TD0810 | Length 100 mm; Outer Diameter 8 mm; Catheter Gauge 8 Fr | MR Conditional | Available |
| TD0812 | Length 120 mm; Outer Diameter 8 mm; Catheter Gauge 8 Fr | MR Conditional | Available |
| TD1004 | Length 40 mm; Outer Diameter 10 mm; Catheter Gauge 8 Fr | MR Conditional | Available |
| TD1005 | Length 50 mm; Outer Diameter 10 mm; Catheter Gauge 8 Fr | MR Conditional | Available |
| TD1006 | Length 60 mm; Outer Diameter 10 mm; Catheter Gauge 8 Fr | MR Conditional | Available |
| TD1007 | Length 70 mm; Outer Diameter 10 mm; Catheter Gauge 8 Fr | MR Conditional | Available |
| TD1008 | Length 80 mm; Outer Diameter 10 mm; Catheter Gauge 8 Fr | MR Conditional | Available |
| TD1009 | Length 90 mm; Outer Diameter 10 mm; Catheter Gauge 8 Fr | MR Conditional | Available |
| TD1010 | Length 100 mm; Outer Diameter 10 mm; Catheter Gauge 8 Fr | MR Conditional | Available |
| TD1012 | Length 120 mm; Outer Diameter 10 mm; Catheter Gauge 8 Fr | MR Conditional | Available |
FDA clearances
- 510(k) K251123 December 2025
- 510(k) K073667 November 2008
Procedures that use biliary drains
Frequently asked questions
What is Niti-S Biliary Stent 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 Niti-S Biliary Stent?
Niti-S Biliary Stent is made by Taewoongmedical.co.,ltd. It is listed under biliary drainage catheters in our device library.
What sizes does Niti-S Biliary Stent come in?
Sizes listed for Niti-S Biliary Stent: Length: 40–120 mm; Outer Diameter: 8–10 mm; Catheter Gauge: 8 Fr. Confirm availability with the manufacturer's instructions for use.
Is Niti-S Biliary Stent MRI safe?
The FDA device database lists Niti-S Biliary Stent as MR Conditional. Always follow the specific MRI conditions in the labeling.
Is Niti-S Biliary Stent FDA cleared?
Niti-S Biliary Stent is covered by FDA submissions K073667, K251123.
How do I contact a Taewoongmedical.co.,ltd sales representative?
Taewoongmedical.co.,ltd has not listed representatives on LA Vascular yet. Visit the Taewoongmedical.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.