Biliary drains
HANAROSTENT FAST^TM Biliary (NNN)
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 HANAROSTENT FAST^TM Biliary (NNN)
We do not have contact details for M.I.Tech Co., Ltd. yet. Send a request and we will route it to the right person for your country.
HANAROSTENT FAST^TM Biliary (NNN) 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 |
|---|---|---|---|
| SHS-08-040-S180 | Stent Diameter 08 mm; Stent Length 40 mm | MR Conditional | Available |
| SHS-08-050-S180 | Stent Length 50 mm; Stent Diameter 08 mm | MR Conditional | Available |
| SHS-08-060-S180 | Stent Diameter 08 mm; Stent Length 60 mm | MR Conditional | Available |
| SHS-08-070-S180 | Stent Length 70 mm; Stent Diameter 08 mm | MR Conditional | Available |
| SHS-08-080-S180 | Stent Diameter 08 mm; Stent Length 80 mm | MR Conditional | Available |
| SHS-08-090-S180 | Stent Length 90 mm; Stent Diameter 08 mm | MR Conditional | Available |
| SHS-08-100-S180 | Stent Diameter 08 mm; Stent Length 100 mm | MR Conditional | Available |
| SHS-08-110-S180 | Stent Diameter 08 mm; Stent Length 110 mm | MR Conditional | Available |
| SHS-08-120-S180 | Stent Length 120 mm; Stent Diameter 08 mm | MR Conditional | Available |
| SHS-10-040-S180 | Stent Diameter 10 mm; Stent Length 40 mm | MR Conditional | Available |
| SHS-10-050-S180 | Stent Length 50 mm; Stent Diameter 10 mm | MR Conditional | Available |
| SHS-10-060-S180 | Stent Diameter 10 mm; Stent Length 60 mm | MR Conditional | Available |
| SHS-10-070-S180 | Stent Length 70 mm; Stent Diameter 10 mm | MR Conditional | Available |
| SHS-10-080-S180 | Stent Diameter 10 mm; Stent Length 80 mm | MR Conditional | Available |
| SHS-10-090-S180 | Stent Length 90 mm; Stent Diameter 10 mm | MR Conditional | Available |
| SHS-10-100-S180 | Stent Diameter 10 mm; Stent Length 100 mm | MR Conditional | Available |
| SHS-10-110-S180 | Stent Length 110 mm; Stent Diameter 10 mm | MR Conditional | Available |
| SHS-10-120-S180 | Stent Diameter 10 mm; Stent Length 120 mm | MR Conditional | Available |
FDA clearances
- 510(k) K183396 February 2019
Procedures that use biliary drains
Frequently asked questions
What is HANAROSTENT FAST^TM Biliary (NNN) 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 HANAROSTENT FAST^TM Biliary (NNN)?
HANAROSTENT FAST^TM Biliary (NNN) is made by M.I.Tech Co., Ltd.. It is listed under biliary drainage catheters in our device library.
What sizes does HANAROSTENT FAST^TM Biliary (NNN) come in?
Sizes listed for HANAROSTENT FAST^TM Biliary (NNN): Stent Length: 40–120 mm; Stent Diameter: 8–10 mm. Confirm availability with the manufacturer's instructions for use.
Is HANAROSTENT FAST^TM Biliary (NNN) MRI safe?
The FDA device database lists HANAROSTENT FAST^TM Biliary (NNN) as MR Conditional. Always follow the specific MRI conditions in the labeling.
Is HANAROSTENT FAST^TM Biliary (NNN) FDA cleared?
HANAROSTENT FAST^TM Biliary (NNN) is covered by FDA submission K183396.
How do I contact a M.I.Tech Co., Ltd. sales representative?
M.I.Tech Co., Ltd. has not listed representatives on LA Vascular yet. Visit the M.I.Tech 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.