Angioplasty balloons
ELM PTA Balloon Dilatation Catheter
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 ELM PTA Balloon Dilatation Catheter
We do not have contact details for Creagh Medical Limited yet. Send a request and we will route it to the right person for your country.
ELM 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. | Size | MRI | Status |
|---|---|---|---|
| ELMEX1240L | Length 40 mm; Outer Diameter 12.0 mm | Not stated | Available |
| ELMEX1440L | Length 40 mm; Outer Diameter 14.0 mm | Not stated | Available |
| ELMEX1640L | Length 40 mm; Outer Diameter 16.0 mm | Not stated | Available |
FDA clearances
- 510(k) K143561 May 2015
Procedures that use angioplasty balloons
Frequently asked questions
What is ELM 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 ELM PTA Balloon Dilatation Catheter?
ELM PTA Balloon Dilatation Catheter is made by Creagh Medical Limited. It is listed under peripheral angioplasty balloons in our device library.
What sizes does ELM PTA Balloon Dilatation Catheter come in?
Sizes listed for ELM PTA Balloon Dilatation Catheter: Length: 40 mm; Outer Diameter: 12–16 mm. Confirm availability with the manufacturer's instructions for use.
Is ELM PTA Balloon Dilatation Catheter MRI safe?
The FDA device database entry for ELM PTA Balloon Dilatation Catheter does not state its MRI safety status. Check the labeling before MRI.
Is ELM PTA Balloon Dilatation Catheter FDA cleared?
ELM PTA Balloon Dilatation Catheter is covered by FDA submission K143561.
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.