Biliary drains
Niti-S Biliary Speed D 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 Speed D Stent
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Niti-S Biliary Speed D 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 |
|---|---|---|---|
| BDM0804 | Stent Diameter 8 mm; Stent Length 40 mm; Catheter Working Length 180 cm; Crossing Profile 8.5 Fr | MR Conditional | Available |
| BDM0805 | Stent Diameter 8 mm; Stent Length 50 mm; Catheter Working Length 180 cm; Crossing Profile 8.5 Fr | MR Conditional | Available |
| BDM0806 | Stent Diameter 8 mm; Stent Length 60 mm; Catheter Working Length 180 cm; Crossing Profile 8.5 Fr | MR Conditional | Available |
| BDM0807 | Stent Diameter 8 mm; Stent Length 70 mm; Catheter Working Length 180 cm; Crossing Profile 8.5 Fr | MR Conditional | Available |
| BDM0808 | Stent Diameter 8 mm; Stent Length 80 mm; Catheter Working Length 180 cm; Crossing Profile 8.5 Fr | MR Conditional | Available |
| BDM0809 | Stent Diameter 8 mm; Stent Length 90 mm; Catheter Working Length 180 cm; Crossing Profile 8.5 Fr | MR Conditional | Available |
| BDM0810 | Stent Diameter 8 mm; Stent Length 100 mm; Catheter Working Length 180 cm; Crossing Profile 8.5 Fr | MR Conditional | Available |
| BDM0812 | Stent Diameter 8 mm; Stent Length 120 mm; Catheter Working Length 180 cm; Crossing Profile 8.5 Fr | MR Conditional | Available |
| BDM1004 | Stent Diameter 10 mm; Stent Length 40 mm; Catheter Working Length 180 cm; Crossing Profile 8.5 Fr | MR Conditional | Available |
| BDM1005 | Stent Diameter 10 mm; Stent Length 50 mm; Catheter Working Length 180 cm; Crossing Profile 8.5 Fr | MR Conditional | Available |
| BDM1006 | Stent Diameter 10 mm; Stent Length 60 mm; Catheter Working Length 180 cm; Crossing Profile 8.5 Fr | MR Conditional | Available |
| BDM1007 | Stent Diameter 10 mm; Stent Length 70 mm; Catheter Working Length 180 cm; Crossing Profile 8.5 Fr | MR Conditional | Available |
| BDM1008 | Stent Diameter 10 mm; Stent Length 80 mm; Catheter Working Length 180 cm; Crossing Profile 8.5 Fr | MR Conditional | Available |
| BDM1009 | Stent Diameter 10 mm; Stent Length 90 mm; Catheter Working Length 180 cm; Crossing Profile 8.5 Fr | MR Conditional | Available |
| BDM1010 | Stent Diameter 10 mm; Stent Length 100 mm; Catheter Working Length 180 cm; Crossing Profile 8.5 Fr | MR Conditional | Available |
| BDM1012 | Stent Diameter 10 mm; Stent Length 120 mm; Catheter Working Length 180 cm; Crossing Profile 8.5 Fr | MR Conditional | Available |
FDA clearances
- 510(k) K223626 May 2023
Procedures that use biliary drains
Frequently asked questions
What is Niti-S Biliary Speed D 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 Speed D Stent?
Niti-S Biliary Speed D Stent is made by Taewoongmedical.co.,ltd. It is listed under biliary drainage catheters in our device library.
What sizes does Niti-S Biliary Speed D Stent come in?
Sizes listed for Niti-S Biliary Speed D Stent: Stent Diameter: 8–10 mm; Stent Length: 40–120 mm; Catheter Working Length: 180 cm. Confirm availability with the manufacturer's instructions for use.
Is Niti-S Biliary Speed D Stent MRI safe?
The FDA device database lists Niti-S Biliary Speed D Stent as MR Conditional. Always follow the specific MRI conditions in the labeling.
Is Niti-S Biliary Speed D Stent FDA cleared?
Niti-S Biliary Speed D Stent is covered by FDA submission K223626.
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.