Infusion catheters

ScleroSafe

by V.v.t. Med Ltd

A flexible dual-lumen tube designed to be percutaneously introduced into an insufficient vein [commonly the greater saphenous vein (GSV)] to inject sclerosing solution and simultaneously aspirate blood, to shrink and close the varicose vein as part of an endovenous chemical ablation procedure. It is intended to be used with a dedicated injection/aspiration syringe which may be provided with the catheter. This is a single-use device.

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Where to buy ScleroSafe

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ScleroSafe models and sizes

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

Model / catalog no.SizeMRIStatus
350— Not statedAvailable

FDA clearances

  • 510(k) K231148 June 2023

Procedures that use infusion catheters

Frequently asked questions

What is ScleroSafe used for?

A flexible dual-lumen tube designed to be percutaneously introduced into an insufficient vein [commonly the greater saphenous vein (GSV)] to inject sclerosing solution and simultaneously aspirate blood, to shrink and close the varicose vein as part of an endovenous chemical ablation procedure. It is intended to be used with a dedicated injection/aspiration syringe which may be provided with the catheter. This is a single-use device.

Who makes ScleroSafe?

ScleroSafe is made by V.v.t. Med Ltd. It is listed under thrombolysis infusion catheters in our device library.

What sizes does ScleroSafe come in?

The FDA device database does not list sizes for ScleroSafe. Check the instructions for use or ask a V.v.t. Med Ltd representative.

Is ScleroSafe MRI safe?

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

Is ScleroSafe FDA cleared?

ScleroSafe is covered by FDA submission K231148.

How do I contact a V.v.t. Med Ltd sales representative?

V.v.t. Med Ltd has not listed representatives on LA Vascular yet. Visit the V.v.t. Med 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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