Biliary drains

Lumiflex

by US Endoscopy

A long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, may be of the fixed-wire or wire-guided type, and is not coated with a drug/pharmaceutical. This is a single-use device.

Ask about this device Where to buy Compare similar devices

Find similar drainage catheters

Where to buy Lumiflex

We do not have contact details for US Endoscopy yet. Send a request and we will route it to the right person for your country.

Request this device

Is this your product? Claim US Endoscopy to list your reps and distributors by country and receive buyer requests from your territories.

Lumiflex models and sizes

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

Model / catalog no.SizeMRIStatus
00715506Catheter Length 240 cm; Balloon Length 5.5 cm Not statedAvailable
00715506WGuidewire Diameter 0.89 mm; Catheter Length 240 cm; Balloon Length 5.5 cm Not statedAvailable
00715508Balloon Length 5.5 cm; Catheter Length 240 cm Not statedAvailable
00715508WBalloon Length 5.5 cm; Guidewire Diameter 0.89 mm; Catheter Length 240 cm Not statedAvailable
00715510Balloon Length 5.5 cm; Catheter Length 240 cm Not statedAvailable
00715510WGuidewire Diameter 0.89 mm; Catheter Length 240 cm; Balloon Length 5.5 cm Not statedAvailable
00715512Catheter Length 240 cm; Balloon Length 5.5 cm Not statedAvailable
00715512WGuidewire Diameter 0.89 mm; Balloon Length 5.5 cm; Catheter Length 240 cm Not statedAvailable
00715515Catheter Length 240 cm; Balloon Length 5.5 cm Not statedAvailable
00715515WBalloon Length 5.5 cm; Catheter Length 240 cm; Guidewire Diameter 0.89 mm Not statedAvailable
00715518Balloon Length 5.5 cm; Catheter Length 240 cm Not statedAvailable
00715518WGuidewire Diameter 0.89 mm; Balloon Length 5.5 cm; Catheter Length 240 cm Not statedAvailable
00718006WCatheter Length 180 cm; Balloon Length 8 cm; Guidewire Diameter 0.89 mm Not statedAvailable
00718008WCatheter Length 180 cm; Balloon Length 8 cm; Guidewire Diameter 0.89 mm Not statedAvailable
00718010WBalloon Length 8 cm; Guidewire Diameter 0.89 mm; Catheter Length 180 cm Not statedAvailable
00718012WBalloon Length 8 cm; Guidewire Diameter 0.89 mm; Catheter Length 180 cm Not statedAvailable
00718015WBalloon Length 8 cm; Catheter Length 180 cm; Guidewire Diameter 0.89 mm Not statedAvailable
00718018WGuidewire Diameter 0.89 mm; Balloon Length 8 cm; Catheter Length 180 cm Not statedAvailable

FDA clearances

  • 510(k) K241888 December 2024

Procedures that use biliary drains

Frequently asked questions

What is Lumiflex used for?

A long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, may be of the fixed-wire or wire-guided type, and is not coated with a drug/pharmaceutical. This is a single-use device.

Who makes Lumiflex?

Lumiflex is made by US Endoscopy. It is listed under biliary drainage catheters in our device library.

What sizes does Lumiflex come in?

Sizes listed for Lumiflex: Balloon Length: 5.5–8 cm; Catheter Length: 180–240 cm; Guidewire Diameter: 0.89 mm. Confirm availability with the manufacturer's instructions for use.

Is Lumiflex MRI safe?

The FDA device database entry for Lumiflex does not state its MRI safety status. Check the labeling before MRI.

Is Lumiflex FDA cleared?

Lumiflex is covered by FDA submission K241888.

How do I contact a US Endoscopy sales representative?

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

πŸ“¬ The IR Device Brief

One email a month: new FDA clearances, recalls and device pages in vascular & interventional radiology.

We'll email you a link to confirm. Unsubscribe any time.

Suggest edits

For manufacturers and their teams. Each field shows what the page says now: add, remove or rewrite anything, and leave the rest as is. LA Vascular reviews every change before it goes live.

About you