Angioplasty balloons

Elm HP PTA

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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Elm HP PTA models and sizes

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

Model / catalog no.SizeMRIStatus
ELM340LLength 40 mm; Outer Diameter 3.0 mm Not statedAvailable
ELM340SLength 40 mm; Outer Diameter 3.0 mm Not statedAvailable
ELM420LLength 20 mm; Outer Diameter 4.0 mm Not statedAvailable
ELM420SLength 20 mm; Outer Diameter 4.0 mm Not statedAvailable
ELM440LLength 40 mm; Outer Diameter 4.0 mm Not statedAvailable
ELM440SLength 40 mm; Outer Diameter 4.0 mm Not statedAvailable
ELM520LLength 20 mm; Outer Diameter 5.0 mm Not statedAvailable
ELM520SLength 20 mm; Outer Diameter 5.0 mm Not statedAvailable
ELM540LLength 40 mm; Outer Diameter 5.0 mm Not statedAvailable
ELM540SLength 40 mm; Outer Diameter 5.0 mm Not statedAvailable
ELM560LLength 60 mm; Outer Diameter 5.0 mm Not statedAvailable
ELM560SLength 60 mm; Outer Diameter 5.0 mm Not statedAvailable
ELM620LLength 20 mm; Outer Diameter 6.0 mm Not statedAvailable
ELM620SLength 20 mm; Outer Diameter 6.0 mm Not statedAvailable
ELM640LLength 40 mm; Outer Diameter 6.0 mm Not statedAvailable
ELM640SLength 40 mm; Outer Diameter 6.0 mm Not statedAvailable
ELM660LLength 60 mm; Outer Diameter 6.0 mm Not statedAvailable
ELM660SLength 60 mm; Outer Diameter 6.0 mm Not statedAvailable
ELM720LLength 20 mm; Outer Diameter 7.0 mm Not statedAvailable
ELM720SLength 20 mm; Outer Diameter 7.0 mm Not statedAvailable
ELM740LLength 40 mm; Outer Diameter 7.0 mm Not statedAvailable
ELM740SLength 40 mm; Outer Diameter 7.0 mm Not statedAvailable
ELM760LLength 60 mm; Outer Diameter 7.0 mm Not statedAvailable
ELM760SLength 60 mm; Outer Diameter 7.0 mm Not statedAvailable
ELM820LLength 20 mm; Outer Diameter 8.0 mm Not statedAvailable
ELM820SLength 20 mm; Outer Diameter 8.0 mm Not statedAvailable
ELM840LLength 40 mm; Outer Diameter 8.0 mm Not statedAvailable
ELM840SLength 40 mm; Outer Diameter 8.0 mm Not statedAvailable
ELM860LLength 60 mm; Outer Diameter 8.0 mm Not statedAvailable
ELM860SLength 60 mm; Outer Diameter 8.0 mm Not statedAvailable
ELM880LLength 80 mm; Outer Diameter 8.0 mm Not statedAvailable
ELM880SLength 80 mm; Outer Diameter 8.0 mm Not statedAvailable
ELM940LLength 40 mm; Outer Diameter 9.0 mm Not statedAvailable
ELM940SLength 40 mm; Outer Diameter 9.0 mm Not statedAvailable
ELM1040LLength 40 mm; Outer Diameter 10.0 mm Not statedAvailable
ELM1040SLength 40 mm; Outer Diameter 10.0 mm Not statedAvailable
ELM1240LLength 40 mm; Outer Diameter 12.0 mm Not statedAvailable
ELM1240SLength 40 mm; Outer Diameter 12.0 mm Not statedAvailable
ELM6100LLength 100 mm; Outer Diameter 6.0 mm Not statedAvailable
ELM6100SLength 100 mm; Outer Diameter 6.0 mm Not statedAvailable
ELM7100LLength 100 mm; Outer Diameter 7.0 mm Not statedAvailable
ELM7100SLength 100 mm; Outer Diameter 7.0 mm Not statedAvailable

FDA clearances

  • 510(k) K102645 December 2010

Procedures that use angioplasty balloons

Frequently asked questions

What is Elm HP PTA 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 HP PTA?

Elm HP PTA is made by Creagh Medical Limited. It is listed under peripheral angioplasty balloons in our device library.

What sizes does Elm HP PTA come in?

Sizes listed for Elm HP PTA: Length: 20–100 mm; Outer Diameter: 3–12 mm. Confirm availability with the manufacturer's instructions for use.

Is Elm HP PTA MRI safe?

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

Is Elm HP PTA FDA cleared?

Elm HP PTA 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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