Angioplasty balloons
Advance Serenity 14
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.
Advance Serenity 14 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 |
|---|---|---|---|
| SER14-120-20-20 | Balloon Length 20 mm; Balloon Diameter 2.0 mm | Not stated | Available |
| SER14-120-20-40 | Balloon Length 40 mm; Balloon Diameter 2.0 mm | Not stated | Available |
| SER14-120-20-60 | Balloon Length 60 mm; Balloon Diameter 2.0 mm | Not stated | Available |
| SER14-120-20-80 | Balloon Length 80 mm; Balloon Diameter 2.0 mm | Not stated | Available |
| SER14-120-20-100 | Balloon Length 100 mm; Balloon Diameter 2.0 mm | Not stated | Available |
| SER14-120-20-150 | Balloon Diameter 2.0 mm; Balloon Length 150 mm | Not stated | Available |
| SER14-120-20-220 | Balloon Diameter 2.0 mm; Balloon Length 220 mm | Not stated | Available |
| SER14-120-25-20 | Balloon Length 20 mm; Balloon Diameter 2.5 mm | Not stated | Available |
| SER14-120-25-40 | Balloon Diameter 2.5 mm; Balloon Length 40 mm | Not stated | Available |
| SER14-120-25-60 | Balloon Diameter 2.5 mm; Balloon Length 60 mm | Not stated | Available |
| SER14-120-25-80 | Balloon Diameter 2.5 mm; Balloon Length 80 mm | Not stated | Available |
| SER14-120-25-100 | Balloon Diameter 2.5 mm; Balloon Length 100 mm | Not stated | Available |
| SER14-120-25-150 | Balloon Length 150 mm; Balloon Diameter 2.5 mm | Not stated | Available |
| SER14-120-25-220 | Balloon Diameter 2.5 mm; Balloon Length 220 mm | Not stated | Available |
| SER14-120-30-20 | Balloon Diameter 3.0 mm; Balloon Length 20 mm | Not stated | Available |
| SER14-120-30-40 | Balloon Diameter 3.0 mm; Balloon Length 40 mm | Not stated | Available |
| SER14-120-30-60 | Balloon Diameter 3.0 mm; Balloon Length 60 mm | Not stated | Available |
| SER14-120-30-80 | Balloon Diameter 3.0 mm; Balloon Length 80 mm | Not stated | Available |
| SER14-120-30-100 | Balloon Diameter 3.0 mm; Balloon Length 100 mm | Not stated | Available |
| SER14-120-30-150 | Balloon Diameter 3.0 mm; Balloon Length 150 mm | Not stated | Available |
| SER14-120-30-220 | Balloon Diameter 3.0 mm; Balloon Length 220 mm | Not stated | Available |
| SER14-120-35-20 | Balloon Diameter 3.5 mm; Balloon Length 20 mm | Not stated | Available |
| SER14-120-35-40 | Balloon Diameter 3.5 mm; Balloon Length 40 mm | Not stated | Available |
| SER14-120-35-60 | Balloon Diameter 3.5 mm; Balloon Length 60 mm | Not stated | Available |
| SER14-120-35-80 | Balloon Diameter 3.5 mm; Balloon Length 80 mm | Not stated | Available |
| SER14-120-35-100 | Balloon Diameter 3.5 mm; Balloon Length 100 mm | Not stated | Available |
| SER14-120-35-150 | Balloon Diameter 3.5 µm; Balloon Length 150 mm | Not stated | Available |
| SER14-120-35-220 | Balloon Diameter 3.5 µm; Balloon Length 220 mm | Not stated | Available |
| SER14-120-40-20 | Balloon Diameter 4.0 mm; Balloon Length 20 mm | Not stated | Available |
| SER14-120-40-40 | Balloon Diameter 4.0 mm; Balloon Length 40 mm | Not stated | Available |
| SER14-120-40-60 | Balloon Diameter 4.0 mm; Balloon Length 60 mm | Not stated | Available |
| SER14-120-40-80 | Balloon Diameter 4.0 mm; Balloon Length 80 mm | Not stated | Available |
| SER14-120-40-100 | Balloon Diameter 4.0 mm; Balloon Length 100 mm | Not stated | Available |
| SER14-120-40-150 | Balloon Diameter 4.0 µm; Balloon Length 150 mm | Not stated | Available |
| SER14-120-40-220 | Balloon Diameter 4.0 mm; Balloon Length 220 mm | Not stated | Available |
| SER14-150-20-20 | Balloon Length 20 mm; Balloon Diameter 2.0 mm | Not stated | Available |
| SER14-150-20-40 | Balloon Length 40 mm; Balloon Diameter 2.0 mm | Not stated | Available |
| SER14-150-20-60 | Balloon Diameter 2.0 mm; Balloon Length 60 mm | Not stated | Available |
| SER14-150-20-80 | Balloon Diameter 2.0 mm; Balloon Length 80 mm | Not stated | Available |
| SER14-150-20-100 | Balloon Diameter 2.0 mm; Balloon Length 100 mm | Not stated | Available |
| SER14-150-20-150 | Balloon Diameter 2.0 mm; Balloon Length 150 mm | Not stated | Available |
| SER14-150-20-220 | Balloon Diameter 2.0 mm; Balloon Length 220 mm | Not stated | Available |
| SER14-150-25-20 | Balloon Diameter 2.5 mm; Balloon Length 20 mm | Not stated | Available |
| SER14-150-25-40 | Balloon Diameter 2.5 mm; Balloon Length 40 mm | Not stated | Available |
| SER14-150-25-60 | Balloon Diameter 2.5 mm; Balloon Length 60 mm | Not stated | Available |
| SER14-150-25-80 | Balloon Diameter 2.5 mm; Balloon Length 80 mm | Not stated | Available |
| SER14-150-25-100 | Balloon Diameter 2.5 mm; Balloon Length 100 mm | Not stated | Available |
| SER14-150-25-150 | Balloon Diameter 2.5 mm; Balloon Length 150 mm | Not stated | Available |
| SER14-150-25-220 | Balloon Diameter 2.5 mm; Balloon Length 220 mm | Not stated | Available |
| SER14-150-30-20 | Balloon Diameter 3.0 mm; Balloon Length 20 mm | Not stated | Available |
| SER14-150-30-40 | Balloon Diameter 3.0 mm; Balloon Length 40 mm | Not stated | Available |
| SER14-150-30-60 | Balloon Diameter 3.0 mm; Balloon Length 60 mm | Not stated | Available |
| SER14-150-30-80 | Balloon Diameter 3.0 mm; Balloon Length 80 mm | Not stated | Available |
| SER14-150-30-100 | Balloon Diameter 3.0 mm; Balloon Length 100 mm | Not stated | Available |
| SER14-150-30-150 | Balloon Diameter 3.0 mm; Balloon Length 150 mm | Not stated | Available |
| SER14-150-30-220 | Balloon Diameter 3.0 mm; Balloon Length 220 mm | Not stated | Available |
| SER14-150-35-20 | Balloon Diameter 3.5 mm; Balloon Length 20 mm | Not stated | Available |
| SER14-150-35-40 | Balloon Diameter 3.5 mm; Balloon Length 40 mm | Not stated | Available |
| SER14-150-35-60 | Balloon Diameter 3.5 mm; Balloon Length 60 mm | Not stated | Available |
| SER14-150-35-80 | Balloon Diameter 3.5 mm; Balloon Length 80 mm | Not stated | Available |
| SER14-150-35-100 | Balloon Diameter 3.5 mm; Balloon Length 100 mm | Not stated | Available |
| SER14-150-35-150 | Balloon Diameter 3.5 mm; Balloon Length 150 mm | Not stated | Available |
| SER14-150-35-220 | Balloon Diameter 3.5 mm; Balloon Length 220 mm | Not stated | Available |
| SER14-150-40-20 | Balloon Diameter 4.0 mm; Balloon Length 20 mm | Not stated | Available |
| SER14-150-40-40 | Balloon Diameter 4.0 mm; Balloon Length 40 mm | Not stated | Available |
| SER14-150-40-60 | Balloon Diameter 4.0 mm; Balloon Length 60 mm | Not stated | Available |
| SER14-150-40-80 | Balloon Diameter 4.0 mm; Balloon Length 80 mm | Not stated | Available |
| SER14-150-40-100 | Balloon Diameter 4.0 mm; Balloon Length 100 mm | Not stated | Available |
| SER14-150-40-150 | Balloon Diameter 4.0 mm; Balloon Length 150 mm | Not stated | Available |
| SER14-150-40-220 | Balloon Diameter 4.0 mm; Balloon Length 220 mm | Not stated | Available |
FDA clearances
- 510(k) K171251 September 2017
Procedures that use angioplasty balloons
Frequently asked questions
What is Advance Serenity 14 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 14?
Advance Serenity 14 is made by Creagh Medical Limited. It is listed under peripheral angioplasty balloons in our device library.
What sizes does Advance Serenity 14 come in?
Sizes listed for Advance Serenity 14: Balloon Length: 20–220 mm; Balloon Diameter: 2–4 mm; Balloon Diameter: 3.5–4 µm. Confirm availability with the manufacturer's instructions for use.
Is Advance Serenity 14 MRI safe?
The FDA device database entry for Advance Serenity 14 does not state its MRI safety status. Check the labeling before MRI.
Is Advance Serenity 14 FDA cleared?
Advance Serenity 14 is covered by FDA submission K171251.
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.