Angioplasty balloons
Advance Serenity 18 Hydrophilic 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 Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter
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Advance Serenity 18 Hydrophilic 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 |
|---|---|---|---|
| SER18-135-50-220 | Balloon Diameter 5.0 mm; Balloon Length 220 mm; Catheter Working Length 135 cm | Not stated | Available |
| SER18-135-60-220 | Balloon Diameter 6.0 mm; Balloon Length 220 mm; Catheter Working Length 135 cm | Not stated | Available |
| SER18-135-70-220 | Balloon Diameter 7.0 mm; Balloon Length 220 mm; Catheter Working Length 135 cm | Not stated | Available |
FDA clearances
- 510(k) K242419 November 2024
Procedures that use angioplasty balloons
Frequently asked questions
What is Advance Serenity 18 Hydrophilic 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 Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter?
Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter is made by Creagh Medical Limited. It is listed under peripheral angioplasty balloons in our device library.
What sizes does Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter come in?
Sizes listed for Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter: Balloon Diameter: 5–7 mm; Balloon Length: 220 mm; Catheter Working Length: 135 cm. Confirm availability with the manufacturer's instructions for use.
Is Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter MRI safe?
The FDA device database entry for Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter does not state its MRI safety status. Check the labeling before MRI.
Is Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter FDA cleared?
Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter is covered by FDA submission K242419.
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.