Angioplasty balloons

Tersus-14 BTK

by Creagh Medical Limited

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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Tersus-14 BTK models and sizes

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

Model / catalog no.SizeMRIStatus
BTK2020LLength 20 mm; Outer Diameter 2.0 mm Not statedAvailable
BTK2020SLength 20 mm; Outer Diameter 2.0 mm Not statedAvailable
BTK2060LLength 60 mm; Outer Diameter 2.0 mm Not statedAvailable
BTK2060SLength 60 mm; Outer Diameter 2.0 mm Not statedAvailable
BTK2080LLength 80 mm; Outer Diameter 2.0 mm Not statedAvailable
BTK2080SLength 80 mm; Outer Diameter 2.0 mm Not statedAvailable
BTK2520LLength 20 mm; Outer Diameter 2.5 mm Not statedAvailable
BTK2520SLength 20 mm; Outer Diameter 2.5 mm Not statedAvailable
BTK2560LLength 60 mm; Outer Diameter 2.5 mm Not statedAvailable
BTK2560SLength 60 mm; Outer Diameter 2.5 mm Not statedAvailable
BTK2580LLength 80 mm; Outer Diameter 2.5 mm Not statedAvailable
BTK2580SLength 80 mm; Outer Diameter 2.5 mm Not statedAvailable
BTK3020LLength 20 mm; Outer Diameter 3.0 mm Not statedAvailable
BTK3020SLength 20 mm; Outer Diameter 3.0 mm Not statedAvailable
BTK3060LLength 60 mm; Outer Diameter 3.0 mm Not statedAvailable
BTK3060SLength 60 mm; Outer Diameter 3.0 mm Not statedAvailable
BTK3080LLength 80 mm; Outer Diameter 3.0 mm Not statedAvailable
BTK3080SLength 80 mm; Outer Diameter 3.0 mm Not statedAvailable
BTK3520LLength 20 mm; Outer Diameter 3.5 mm Not statedAvailable
BTK3520SLength 20 mm; Outer Diameter 3.5 mm Not statedAvailable
BTK3560LLength 60 mm; Outer Diameter 3.5 mm Not statedAvailable
BTK3560SLength 60 mm; Outer Diameter 3.5 mm Not statedAvailable
BTK3580LLength 80 mm; Outer Diameter 3.5 mm Not statedAvailable
BTK3580SLength 80 mm; Outer Diameter 3.5 mm Not statedAvailable
BTK4020LLength 20 mm; Outer Diameter 4.0 mm Not statedAvailable
BTK4020SLength 20 mm; Outer Diameter 4.0 mm Not statedAvailable
BTK4060LLength 60 mm; Outer Diameter 4.0 mm Not statedAvailable
BTK4060SLength 60 mm; Outer Diameter 4.0 mm Not statedAvailable
BTK4080LLength 80 mm; Outer Diameter 4.0 mm Not statedAvailable
BTK4080SLength 80 mm; Outer Diameter 4.0 mm Not statedAvailable
BTK20100LLength 100 mm; Outer Diameter 2.0 mm Not statedAvailable
BTK20100SLength 100 mm; Outer Diameter 2.0 mm Not statedAvailable
BTK20150LLength 150 mm; Outer Diameter 2.0 mm Not statedAvailable
BTK20150SLength 150 mm; Outer Diameter 2.0 mm Not statedAvailable
BTK20220LLength 220 mm; Outer Diameter 2.0 mm Not statedAvailable
BTK20220SLength 220 mm; Outer Diameter 2.0 mm Not statedAvailable
BTK25100LLength 100 mm; Outer Diameter 2.5 mm Not statedAvailable
BTK25100SLength 100 mm; Outer Diameter 2.5 mm Not statedAvailable
BTK25150LLength 150 mm; Outer Diameter 2.5 mm Not statedAvailable
BTK25150SLength 150 mm; Outer Diameter 2.5 mm Not statedAvailable
BTK25220LLength 220 mm; Outer Diameter 2.5 mm Not statedAvailable
BTK25220SLength 220 mm; Outer Diameter 2.5 mm Not statedAvailable
BTK30100LLength 100 mm; Outer Diameter 3.0 mm Not statedAvailable
BTK30100SLength 100 mm; Outer Diameter 3.0 mm Not statedAvailable
BTK30150LLength 150 mm; Outer Diameter 3.0 mm Not statedAvailable
BTK30150SLength 150 mm; Outer Diameter 3.0 mm Not statedAvailable
BTK30220LLength 220 mm; Outer Diameter 3.0 mm Not statedAvailable
BTK30220SLength 220 mm; Outer Diameter 3.0 mm Not statedAvailable
BTK35100LLength 100 mm; Outer Diameter 3.5 mm Not statedAvailable
BTK35100SLength 100 mm; Outer Diameter 3.5 mm Not statedAvailable
BTK35150LLength 150 mm; Outer Diameter 3.5 mm Not statedAvailable
BTK35150SLength 150 mm; Outer Diameter 3.5 mm Not statedAvailable
BTK35220LLength 220 mm; Outer Diameter 3.5 mm Not statedAvailable
BTK35220SLength 220 mm; Outer Diameter 3.5 mm Not statedAvailable
BTK40100LLength 100 mm; Outer Diameter 4.0 mm Not statedAvailable
BTK40100SLength 100 mm; Outer Diameter 4.0 mm Not statedAvailable
BTK40150LLength 150 mm; Outer Diameter 4.0 mm Not statedAvailable
BTK40150SLength 150 mm; Outer Diameter 4.0 mm Not statedAvailable
BTK40220LLength 220 mm; Outer Diameter 4.0 mm Not statedAvailable
BTK40220SLength 220 mm; Outer Diameter 4.0 mm Not statedAvailable

FDA clearances

  • 510(k) K102645 December 2010

Procedures that use angioplasty balloons

Frequently asked questions

What is Tersus-14 BTK 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 Tersus-14 BTK?

Tersus-14 BTK is made by Creagh Medical Limited. It is listed under peripheral angioplasty balloons in our device library.

What sizes does Tersus-14 BTK come in?

Sizes listed for Tersus-14 BTK: Length: 20 mm; Outer Diameter: 2 mm. Confirm availability with the manufacturer's instructions for use.

Is Tersus-14 BTK MRI safe?

The FDA device database entry for Tersus-14 BTK does not state its MRI safety status. Check the labeling before MRI.

Is Tersus-14 BTK FDA cleared?

Tersus-14 BTK is covered by FDA submission K102645.

How do I contact a Creagh Medical Limited sales representative?

Creagh Medical Limited has not listed representatives on LA Vascular yet. Visit the Creagh Medical Limited 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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