Angioplasty balloons
First Choice
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.
First Choice 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 |
|---|---|---|---|
| EUHP75124 | — | Not stated | Available |
| EUHP75144 | — | Not stated | Available |
| EUHP75164 | — | Not stated | Available |
| UHP7534 | — | Not stated | Available |
| UHP7542 | — | Not stated | Available |
| UHP7544 | — | Not stated | Available |
| UHP7552 | — | Not stated | Available |
| UHP7554 | — | Not stated | Available |
| UHP7556 | — | Not stated | Available |
| UHP7562 | — | Not stated | Available |
| UHP7564 | — | Not stated | Available |
| UHP7566 | — | Not stated | Available |
| UHP7572 | — | Not stated | Available |
| UHP7574 | — | Not stated | Available |
| UHP7574s | — | Not stated | Available |
| UHP7576 | — | Not stated | Available |
| UHP7582 | — | Not stated | Available |
| UHP7584 | — | Not stated | Available |
| UHP7584s | — | Not stated | Available |
| UHP7586 | — | Not stated | Available |
| UHP7588 | — | Not stated | Available |
| UHP7594 | — | Not stated | Available |
| UHP75104 | — | Not stated | Available |
| UHP75610 | — | Not stated | Available |
| UHP75710 | — | Not stated | Available |
FDA clearances
- 510(k) K143561 May 2015
- 510(k) K113468 December 2011
- 510(k) K102645 December 2010
Procedures that use angioplasty balloons
Frequently asked questions
What is First Choice 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 First Choice?
First Choice is made by Creagh Medical Limited. It is listed under peripheral angioplasty balloons in our device library.
What sizes does First Choice come in?
The FDA device database does not list sizes for First Choice. Check the instructions for use or ask a Creagh Medical Limited representative.
Is First Choice MRI safe?
The FDA device database entry for First Choice does not state its MRI safety status. Check the labeling before MRI.
Is First Choice FDA cleared?
First Choice is covered by FDA submissions K102645, K143561, K113468.
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.