Angioplasty balloons

Sublime 014 Rx PTA Balloon Dilatation Catheter

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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Where to buy Sublime 014 Rx PTA Balloon Dilatation Catheter

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Sublime 014 Rx PTA Balloon Dilatation Catheter models and sizes

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

Model / catalog no.SizeMRIStatus
SRA-DC14-20020Balloon Length 20 mm; Catheter Length 250 cm; Balloon Diameter 2.0 mm Not statedAvailable
SRA-DC14-20040Balloon Length 20 mm; Catheter Length 250 cm; Balloon Diameter 2.0 mm Not statedAvailable
SRA-DC14-20060Balloon Length 60 mm; Catheter Length 250 cm; Balloon Diameter 2.0 mm Not statedAvailable
SRA-DC14-20080Balloon Length 80 mm; Balloon Diameter 2 mm; Catheter Length 250 cm Not statedAvailable
SRA-DC14-20100Catheter Length 250 cm; Balloon Length 100 mm; Balloon Diameter 2.0 mm Not statedAvailable
SRA-DC14-20150Balloon Length 150 mm; Catheter Length 250 cm; Balloon Diameter 2.0 mm Not statedAvailable
SRA-DC14-20220Balloon Length 220 mm; Catheter Length 250 cm; Balloon Diameter 2.0 mm Not statedAvailable
SRA-DC14-25020Balloon Diameter 2.5 mm; Balloon Length 20 µm; Catheter Length 250 cm Not statedAvailable
SRA-DC14-25040Balloon Diameter 2.5 mm; Balloon Length 40 mm; Catheter Length 250 cm Not statedAvailable
SRA-DC14-25060Balloon Diameter 2.5 mm; Balloon Length 60 mm; Catheter Length 250 cm Not statedAvailable
SRA-DC14-25080Balloon Diameter 2.5 mm; Balloon Length 80 mm; Catheter Length 250 cm Not statedAvailable
SRA-DC14-25100Balloon Diameter 2.5 mm; Balloon Length 100 mm; Catheter Length 250 cm Not statedAvailable
SRA-DC14-25150Balloon Diameter 2.5 mm; Balloon Length 150 mm; Catheter Length 250 cm Not statedAvailable
SRA-DC14-25220Balloon Length 2.5 mm; Balloon Diameter 220 mm; Catheter Length 250 cm Not statedAvailable
SRA-DC14-30020Balloon Diameter 3.0 mm; Balloon Length 20 mm; Catheter Length 250 cm Not statedAvailable
SRA-DC14-30040Balloon Diameter 3.0 mm; Balloon Length 40 mm; Catheter Length 250 cm Not statedAvailable
SRA-DC14-30060Balloon Diameter 3.0 mm; Balloon Length 60 mm; Catheter Length 250 cm Not statedAvailable
SRA-DC14-30080Balloon Diameter 3.0 mm; Balloon Length 80 mm; Catheter Length 250 cm Not statedAvailable
SRA-DC14-30100Balloon Diameter 3.0 mm; Balloon Length 100 mm; Catheter Length 250 cm Not statedAvailable
SRA-DC14-30150Balloon Diameter 3.0 mm; Balloon Length 150 mm; Catheter Length 250 cm Not statedAvailable
SRA-DC14-30220Balloon Diameter 3.0 mm; Balloon Length 220 mm; Catheter Length 250 cm Not statedAvailable
SRA-DC14-35020Balloon Diameter 3.5 mm; Balloon Length 20 mm; Catheter Length 250 cm Not statedAvailable
SRA-DC14-35040Balloon Diameter 3.5 mm; Balloon Length 40 mm; Catheter Length 250 cm Not statedAvailable
SRA-DC14-35060Balloon Diameter 3.5 mm; Balloon Length 60 mm; Catheter Length 250 cm Not statedAvailable
SRA-DC14-35080Balloon Diameter 3.5 mm; Balloon Length 80 mm; Catheter Length 250 cm Not statedAvailable
SRA-DC14-35100Balloon Diameter 3.5 mm; Balloon Length 100 mm; Catheter Length 250 cm Not statedAvailable
SRA-DC14-35150Balloon Diameter 3.5 mm; Balloon Length 150 mm; Catheter Length 250 cm Not statedAvailable
SRA-DC14-35220Balloon Diameter 3.5 mm; Balloon Length 220 mm; Catheter Length 250 cm Not statedAvailable
SRA-DC14-40020Balloon Diameter 4.0 mm; Balloon Length 20 mm; Catheter Length 250 cm Not statedAvailable
SRA-DC14-40040Balloon Diameter 4.0 mm; Balloon Length 40 mm; Catheter Length 250 cm Not statedAvailable
SRA-DC14-40060Balloon Diameter 4.0 mm; Balloon Length 60 mm; Catheter Length 250 cm Not statedAvailable
SRA-DC14-40080Balloon Diameter 4.0 mm; Balloon Length 80 mm; Catheter Length 250 cm Not statedAvailable
SRA-DC14-40100Balloon Diameter 4.0 mm; Balloon Length 100 mm; Catheter Length 250 cm Not statedAvailable
SRA-DC14-40150Balloon Diameter 4.0 mm; Balloon Length 150 mm; Catheter Length 250 cm Not statedAvailable
SRA-DC14-40220Balloon Diameter 4.0 mm; Balloon Length 220 mm; Catheter Length 250 cm Not statedAvailable

FDA clearances

  • 510(k) K200700 May 2020

Procedures that use angioplasty balloons

Frequently asked questions

What is Sublime 014 Rx PTA Balloon Dilatation Catheter 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 Sublime 014 Rx PTA Balloon Dilatation Catheter?

Sublime 014 Rx PTA Balloon Dilatation Catheter is made by Creagh Medical Limited. It is listed under peripheral angioplasty balloons in our device library.

What sizes does Sublime 014 Rx PTA Balloon Dilatation Catheter come in?

Sizes listed for Sublime 014 Rx PTA Balloon Dilatation Catheter: Balloon Diameter: 2–220 mm; Catheter Length: 250 cm; Balloon Length: 2.5–220 mm. Confirm availability with the manufacturer's instructions for use.

Is Sublime 014 Rx PTA Balloon Dilatation Catheter MRI safe?

The FDA device database entry for Sublime 014 Rx PTA Balloon Dilatation Catheter does not state its MRI safety status. Check the labeling before MRI.

Is Sublime 014 Rx PTA Balloon Dilatation Catheter FDA cleared?

Sublime 014 Rx PTA Balloon Dilatation Catheter is covered by FDA submission K200700.

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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