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Angioplasty balloons

Crosstella RX

by Kaneka Corporation

A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.

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Where to buy Crosstella RX

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Crosstella RX models and sizes

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

Model / catalog no.SizeMRIStatus
BD-F20020ER— Not statedAvailable
BD-F20020LR— Not statedAvailable
BD-F20020MR— Not statedAvailable
BD-F20040ER— Not statedAvailable
BD-F20040LR— Not statedAvailable
BD-F20040MR— Not statedAvailable
BD-F20060ER— Not statedAvailable
BD-F20060LR— Not statedAvailable
BD-F20060MR— Not statedAvailable
BD-F20080ER— Not statedAvailable
BD-F20080LR— Not statedAvailable
BD-F20080MR— Not statedAvailable
BD-F20100ER— Not statedAvailable
BD-F20100LR— Not statedAvailable
BD-F20100MR— Not statedAvailable
BD-F20120ER— Not statedAvailable
BD-F20120LR— Not statedAvailable
BD-F20120MR— Not statedAvailable
BD-F20150ER— Not statedAvailable
BD-F20150LR— Not statedAvailable
BD-F20150MR— Not statedAvailable
BD-F20200ER— Not statedAvailable
BD-F20200LR— Not statedAvailable
BD-F20200MR— Not statedAvailable
BD-F25020ER— Not statedAvailable
BD-F25020LR— Not statedAvailable
BD-F25020MR— Not statedAvailable
BD-F25040ER— Not statedAvailable
BD-F25040LR— Not statedAvailable
BD-F25040MR— Not statedAvailable
BD-F25060ER— Not statedAvailable
BD-F25060LR— Not statedAvailable
BD-F25060MR— Not statedAvailable
BD-F25080ER— Not statedAvailable
BD-F25080LR— Not statedAvailable
BD-F25080MR— Not statedAvailable
BD-F25100ER— Not statedAvailable
BD-F25100LR— Not statedAvailable
BD-F25100MR— Not statedAvailable
BD-F25120ER— Not statedAvailable
BD-F25120LR— Not statedAvailable
BD-F25120MR— Not statedAvailable
BD-F25150ER— Not statedAvailable
BD-F25150LR— Not statedAvailable
BD-F25150MR— Not statedAvailable
BD-F25200ER— Not statedAvailable
BD-F25200LR— Not statedAvailable
BD-F25200MR— Not statedAvailable
BD-F30020ER— Not statedAvailable
BD-F30020LR— Not statedAvailable
BD-F30020MR— Not statedAvailable
BD-F30040ER— Not statedAvailable
BD-F30040LR— Not statedAvailable
BD-F30040MR— Not statedAvailable
BD-F30060ER— Not statedAvailable
BD-F30060LR— Not statedAvailable
BD-F30060MR— Not statedAvailable
BD-F30080ER— Not statedAvailable
BD-F30080LR— Not statedAvailable
BD-F30080MR— Not statedAvailable
BD-F30100ER— Not statedAvailable
BD-F30100LR— Not statedAvailable
BD-F30100MR— Not statedAvailable
BD-F30120ER— Not statedAvailable
BD-F30120LR— Not statedAvailable
BD-F30120MR— Not statedAvailable
BD-F30150ER— Not statedAvailable
BD-F30150LR— Not statedAvailable
BD-F30150MR— Not statedAvailable
BD-F30200ER— Not statedAvailable
BD-F30200LR— Not statedAvailable
BD-F30200MR— Not statedAvailable
BD-F40020ER— Not statedAvailable
BD-F40020LR— Not statedAvailable
BD-F40020MR— Not statedAvailable
BD-F40040ER— Not statedAvailable
BD-F40040LR— Not statedAvailable
BD-F40040MR— Not statedAvailable
BD-F40060ER— Not statedAvailable
BD-F40060LR— Not statedAvailable
BD-F40060MR— Not statedAvailable
BD-F40080ER— Not statedAvailable
BD-F40080LR— Not statedAvailable
BD-F40080MR— Not statedAvailable
BD-F40100ER— Not statedAvailable
BD-F40100LR— Not statedAvailable
BD-F40100MR— Not statedAvailable
BD-F40120ER— Not statedAvailable
BD-F40120LR— Not statedAvailable
BD-F40120MR— Not statedAvailable
BD-F40150ER— Not statedAvailable
BD-F40150LR— Not statedAvailable
BD-F40150MR— Not statedAvailable
BD-F40200ER— Not statedAvailable
BD-F40200LR— Not statedAvailable
BD-F40200MR— Not statedAvailable
BD-F50020ER— Not statedAvailable
BD-F50020LR— Not statedAvailable
BD-F50020MR— Not statedAvailable
BD-F50040ER— Not statedAvailable
BD-F50040LR— Not statedAvailable
BD-F50040MR— Not statedAvailable
BD-F50060ER— Not statedAvailable
BD-F50060LR— Not statedAvailable
BD-F50060MR— Not statedAvailable
BD-F50080ER— Not statedAvailable
BD-F50080LR— Not statedAvailable
BD-F50080MR— Not statedAvailable
BD-F50100ER— Not statedAvailable
BD-F50100LR— Not statedAvailable
BD-F50100MR— Not statedAvailable
BD-F50120ER— Not statedAvailable
BD-F50120LR— Not statedAvailable
BD-F50120MR— Not statedAvailable
BD-F50150ER— Not statedAvailable
BD-F50150LR— Not statedAvailable
BD-F50150MR— Not statedAvailable
BD-F50200ER— Not statedAvailable
BD-F50200LR— Not statedAvailable
BD-F50200MR— Not statedAvailable
BD-F60020ER— Not statedAvailable
BD-F60020LR— Not statedAvailable
BD-F60020MR— Not statedAvailable
BD-F60040ER— Not statedAvailable
BD-F60040LR— Not statedAvailable
BD-F60040MR— Not statedAvailable
BD-F60060ER— Not statedAvailable
BD-F60060LR— Not statedAvailable
BD-F60060MR— Not statedAvailable
BD-F60080ER— Not statedAvailable
BD-F60080LR— Not statedAvailable
BD-F60080MR— Not statedAvailable
BD-F60100ER— Not statedAvailable
BD-F60100LR— Not statedAvailable
BD-F60100MR— Not statedAvailable
BD-F60120ER— Not statedAvailable
BD-F60120LR— Not statedAvailable
BD-F60120MR— Not statedAvailable
BD-F60150ER— Not statedAvailable
BD-F60150LR— Not statedAvailable
BD-F60150MR— Not statedAvailable
BD-F60200ER— Not statedAvailable
BD-F60200LR— Not statedAvailable
BD-F60200MR— Not statedAvailable

FDA clearances

  • 510(k) K152873 January 2016

Procedures that use angioplasty balloons

DVT Mechanical ThrombectomyVenous Stenting (Iliac and Central Veins)Peripheral Balloon AngioplastyPeripheral Artery StentingPeripheral AtherectomyFistulogram with AngioplastyDialysis Graft and Fistula ThrombectomyTIPS (Transjugular Intrahepatic Portosystemic Shunt)

Frequently asked questions

What is Crosstella RX used for?

A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.

Who makes Crosstella RX?

Crosstella RX is made by Kaneka Corporation. It is listed under peripheral angioplasty balloons in our device library.

What sizes does Crosstella RX come in?

The FDA device database does not list sizes for Crosstella RX. Check the instructions for use or ask a Kaneka Corporation representative.

Is Crosstella RX MRI safe?

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

Is Crosstella RX FDA cleared?

Crosstella RX is covered by FDA submission K152873.

How do I contact a Kaneka Corporation sales representative?

Kaneka Corporation has not listed representatives on LA Vascular yet. Visit the Kaneka Corporation 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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