Biliary drains

Smart Flex

by Cordis US Corp.

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 Smart Flex

Contact Cordis US Corp. directly; they can quote, ship, or point you to the distributor for your country.

From cordis.com, checked October 2026.

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Smart Flex models and sizes

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

Model / catalog no.SizeMRIStatus
SF05030MBLength 120 cm MR ConditionalAvailable
SF05040MBLength 120 cm MR ConditionalAvailable
SF05060MBLength 120 cm MR ConditionalAvailable
SF05080MBLength 120 cm MR ConditionalAvailable
SF05100MBLength 120 cm MR ConditionalAvailable
SF05120MBLength 120 cm MR ConditionalAvailable
SF06040MBLength 120 cm MR ConditionalAvailable
SF06060MBLength 120 cm MR ConditionalAvailable
SF06080MBLength 120 cm MR ConditionalAvailable
SF06100MBLength 120 cm MR ConditionalAvailable
SF06120MBLength 120 cm MR ConditionalAvailable
SF06150MBLength 120 cm MR ConditionalAvailable
SF07030MBLength 120 cm MR ConditionalAvailable
SF07040MBLength 120 cm MR ConditionalAvailable
SF07060MBLength 120 cm MR ConditionalAvailable
SF07080MBLength 120 cm MR ConditionalAvailable
SF07100MBLength 120 cm MR ConditionalAvailable
SF07120MBLength 120 cm MR ConditionalAvailable
SF07150MBLength 120 cm MR ConditionalAvailable
SF08030MBLength 120 cm MR ConditionalAvailable
SF08030SBLength 80 cm MR ConditionalAvailable
SF08040MBLength 120 cm MR ConditionalAvailable
SF08040SBLength 80 cm MR ConditionalAvailable
SF08060MBLength 120 cm MR ConditionalAvailable
SF08060SBLength 80 cm MR ConditionalAvailable
SF08100MBLength 120 cm MR ConditionalAvailable
SF08120MBLength 120 cm MR ConditionalAvailable
SF08150MBLength 120 cm MR ConditionalAvailable
SF09030MBLength 120 cm MR ConditionalAvailable
SF09030SBLength 80 cm MR ConditionalAvailable
SF09040MBLength 120 cm MR ConditionalAvailable
SF09040SBLength 80 cm MR ConditionalAvailable
SF09060MBLength 120 cm MR ConditionalAvailable
SF09060SBLength 80 cm MR ConditionalAvailable
SF09080MBLength 120 cm MR ConditionalAvailable
SF09100MBLength 120 cm MR ConditionalAvailable
SF09100SBLength 80 cm MR ConditionalAvailable
SF10030MBLength 120 cm MR ConditionalAvailable
SF10030SBLength 80 cm MR ConditionalAvailable
SF10040SBLength 80 cm MR ConditionalAvailable
SF10060MBLength 120 cm MR ConditionalAvailable
SF10060SBLength 80 cm MR ConditionalAvailable
SF10100MBLength 120 cm MR ConditionalAvailable
SF10100SBLength 80 cm MR ConditionalAvailable

FDA clearances

  • 510(k) K121125 July 2012

Procedures that use biliary drains

Frequently asked questions

What is Smart Flex 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 Smart Flex?

Smart Flex is made by Cordis US Corp.. It is listed under biliary drainage catheters in our device library.

What sizes does Smart Flex come in?

Sizes listed for Smart Flex: Length: 80–120 cm. Confirm availability with the manufacturer's instructions for use.

Is Smart Flex MRI safe?

The FDA device database lists Smart Flex as MR Conditional. Always follow the specific MRI conditions in the labeling.

Is Smart Flex FDA cleared?

Smart Flex is covered by FDA submission K121125.

How do I contact a Cordis US Corp. sales representative?

Cordis US Corp. has not listed representatives on LA Vascular yet. Visit the Cordis US Corp. 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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