Biliary drains

Niti-S Biliary Slim M Stent

by Taewoongmedical.co.,ltd

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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Niti-S Biliary Slim M Stent models and sizes

From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.

Model / catalog no.SizeMRIStatus
BN0604-6Stent Diameter 6 mm; Stent Length 40 mm; Catheter Working Length 180 cm; Crossing Profile 6 Fr MR ConditionalAvailable
BN0605-6Stent Diameter 6 mm; Stent Length 50 mm; Catheter Working Length 180 cm; Crossing Profile 6 Fr MR ConditionalAvailable
BN0606-6Stent Diameter 6 mm; Stent Length 60 mm; Catheter Working Length 180 cm; Crossing Profile 6 Fr MR ConditionalAvailable
BN0607-6Stent Diameter 6 mm; Stent Length 70 mm; Catheter Working Length 180 cm; Crossing Profile 6 Fr MR ConditionalAvailable
BN0608-6Stent Diameter 6 mm; Stent Length 80 mm; Catheter Working Length 180 cm; Crossing Profile 6 Fr MR ConditionalAvailable
BN0609-6Stent Diameter 6 mm; Stent Length 90 mm; Catheter Working Length 180 cm; Crossing Profile 6 Fr MR ConditionalAvailable
BN0610-6Stent Diameter 6 mm; Stent Length 100 mm; Catheter Working Length 180 cm; Crossing Profile 6 Fr MR ConditionalAvailable
BN0612-6Stent Diameter 6 mm; Stent Length 120 mm; Catheter Working Length 180 cm; Crossing Profile 6 Fr MR ConditionalAvailable
BN0804-6Stent Diameter 8 mm; Stent Length 40 mm; Catheter Working Length 180 cm; Crossing Profile 6 Fr MR ConditionalAvailable
BN0805-6Stent Diameter 8 mm; Stent Length 50 mm; Catheter Working Length 180 cm; Crossing Profile 6 Fr MR ConditionalAvailable
BN0806-6Stent Diameter 8 mm; Stent Length 60 mm; Catheter Working Length 180 cm; Crossing Profile 6 Fr MR ConditionalAvailable
BN0807-6Stent Diameter 8 mm; Stent Length 70 mm; Catheter Working Length 180 cm; Crossing Profile 6 Fr MR ConditionalAvailable
BN0808-6Stent Diameter 8 mm; Stent Length 80 mm; Catheter Working Length 180 cm; Crossing Profile 6 Fr MR ConditionalAvailable
BN0809-6Stent Diameter 8 mm; Stent Length 90 mm; Catheter Working Length 180 cm; Crossing Profile 6 Fr MR ConditionalAvailable
BN0810-6Stent Diameter 8 mm; Stent Length 100 mm; Catheter Working Length 180 cm; Crossing Profile 6 Fr MR ConditionalAvailable
BN0812-6Stent Diameter 8 mm; Stent Length 120 mm; Catheter Working Length 180 cm; Crossing Profile 6 Fr MR ConditionalAvailable

FDA clearances

  • 510(k) K251123 December 2025
  • 510(k) K221071 June 2022

Procedures that use biliary drains

Frequently asked questions

What is Niti-S Biliary Slim M 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 Slim M Stent?

Niti-S Biliary Slim M Stent is made by Taewoongmedical.co.,ltd. It is listed under biliary drainage catheters in our device library.

What sizes does Niti-S Biliary Slim M Stent come in?

Sizes listed for Niti-S Biliary Slim M Stent: Stent Diameter: 6–8 mm; Stent Length: 40–120 mm; Catheter Working Length: 180 cm. Confirm availability with the manufacturer's instructions for use.

Is Niti-S Biliary Slim M Stent MRI safe?

The FDA device database lists Niti-S Biliary Slim M Stent as MR Conditional. Always follow the specific MRI conditions in the labeling.

Is Niti-S Biliary Slim M Stent FDA cleared?

Niti-S Biliary Slim M Stent is covered by FDA submissions K221071, 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.

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