Biliary drains

Disposable Progressive Pressure Dilators

by Telemed Systems

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.

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Disposable Progressive Pressure Dilators models and sizes

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

Model / catalog no.SizeMRIStatus
1415Length 8 cm; Length 200 cm Not statedAvailable
1418Length 8 cm; Length 200 cm Not statedAvailable

FDA clearances

  • 510(k) K020379 May 2002

Procedures that use biliary drains

Frequently asked questions

What is Disposable Progressive Pressure Dilators 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 Disposable Progressive Pressure Dilators?

Disposable Progressive Pressure Dilators is made by Telemed Systems. It is listed under biliary drainage catheters in our device library.

What sizes does Disposable Progressive Pressure Dilators come in?

Sizes listed for Disposable Progressive Pressure Dilators: Length: 8–200 cm. Confirm availability with the manufacturer's instructions for use.

Is Disposable Progressive Pressure Dilators MRI safe?

The FDA device database entry for Disposable Progressive Pressure Dilators does not state its MRI safety status. Check the labeling before MRI.

Is Disposable Progressive Pressure Dilators FDA cleared?

Disposable Progressive Pressure Dilators is covered by FDA submission K020379.

How do I contact a Telemed Systems sales representative?

Telemed Systems has not listed representatives on LA Vascular yet. Visit the Telemed Systems 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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