Angioplasty balloons
Finesse Injectable PTA Balloon Dilatation Catheter OTW 014
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 Finesse Injectable PTA Balloon Dilatation Catheter OTW 014
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Finesse Injectable PTA Balloon Dilatation Catheter OTW 014 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 |
|---|---|---|---|
| FS200201508 | Balloon Diameter 2.0 mm; Balloon Length 20 mm; Catheter Working Length 150 cm | Not stated | Available |
| FS200401508 | Balloon Diameter 2.0 mm; Balloon Length 40 mm; Catheter Working Length 150 cm | Not stated | Available |
| FS200601508 | Balloon Diameter 2.0 mm; Balloon Length 60 mm; Catheter Working Length 150 cm | Not stated | Available |
| FS201001508 | Balloon Diameter 2.0 mm; Balloon Length 100 mm; Catheter Working Length 150 cm | Not stated | Available |
| FS202251508 | Balloon Diameter 2.0 mm; Balloon Length 225 mm; Catheter Working Length 150 cm | Not stated | Available |
| FS250201508 | Balloon Diameter 2.5 mm; Balloon Length 20 mm; Catheter Working Length 150 cm | Not stated | Available |
| FS250401508 | Balloon Diameter 2.5 mm; Balloon Length 40 mm; Catheter Working Length 150 cm | Not stated | Available |
| FS250601508 | Balloon Diameter 2.5 mm; Balloon Length 60 mm; Catheter Working Length 150 cm | Not stated | Available |
| FS251001508 | Balloon Diameter 2.5 mm; Balloon Length 100 mm; Catheter Working Length 150 cm | Not stated | Available |
| FS252251508 | Balloon Diameter 2.5 mm; Balloon Length 225 mm; Catheter Working Length 150 cm | Not stated | Available |
| FS300201508 | Balloon Diameter 3.0 mm; Balloon Length 20 mm; Catheter Working Length 150 cm | Not stated | Available |
| FS300401508 | Balloon Diameter 3.0 mm; Balloon Length 40 mm; Catheter Working Length 150 cm | Not stated | Available |
| FS300601508 | Balloon Diameter 3.0 mm; Balloon Length 60 mm; Catheter Working Length 150 cm | Not stated | Available |
| FS301001508 | Balloon Diameter 3.0 mm; Balloon Length 100 mm; Catheter Working Length 150 cm | Not stated | Available |
| FS302251508 | Balloon Diameter 3.0 mm; Balloon Length 225 mm; Catheter Working Length 150 cm | Not stated | Available |
| FS350201508 | Balloon Diameter 3.5 mm; Balloon Length 20 mm; Catheter Working Length 150 cm | Not stated | Available |
| FS350401508 | Balloon Diameter 3.5 mm; Balloon Length 40 mm; Catheter Working Length 150 cm | Not stated | Available |
| FS350601508 | Balloon Diameter 3.5 mm; Balloon Length 60 mm; Catheter Working Length 150 cm | Not stated | Available |
| FS351001508 | Balloon Diameter 3.5 mm; Balloon Length 100 mm; Catheter Working Length 150 cm | Not stated | Available |
| FS352251508 | Balloon Diameter 3.5 mm; Balloon Length 225 mm; Catheter Working Length 150 cm | Not stated | Available |
| FS400201508 | Balloon Diameter 4.0 mm; Balloon Length 20 mm; Catheter Working Length 150 cm | Not stated | Available |
| FS400401508 | Balloon Diameter 4.0 mm; Balloon Length 40 mm; Catheter Working Length 150 cm | Not stated | Available |
| FS400601508 | Balloon Diameter 4.0 mm; Balloon Length 60 mm; Catheter Working Length 150 cm | Not stated | Available |
| FS401001508 | Balloon Diameter 4.0 mm; Balloon Length 100 mm; Catheter Working Length 150 cm | Not stated | Available |
| FS402251508 | Balloon Diameter 4.0 mm; Balloon Length 225 mm; Catheter Working Length 150 cm | Not stated | Available |
FDA clearances
- 510(k) K230263 May 2023
Procedures that use angioplasty balloons
Frequently asked questions
What is Finesse Injectable PTA Balloon Dilatation Catheter OTW 014 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 Finesse Injectable PTA Balloon Dilatation Catheter OTW 014?
Finesse Injectable PTA Balloon Dilatation Catheter OTW 014 is made by Summa Therapeutics, LLC. It is listed under peripheral angioplasty balloons in our device library.
What sizes does Finesse Injectable PTA Balloon Dilatation Catheter OTW 014 come in?
Sizes listed for Finesse Injectable PTA Balloon Dilatation Catheter OTW 014: Balloon Diameter: 2–4 mm; Balloon Length: 20–225 mm; Catheter Working Length: 150 cm. Confirm availability with the manufacturer's instructions for use.
Is Finesse Injectable PTA Balloon Dilatation Catheter OTW 014 MRI safe?
The FDA device database entry for Finesse Injectable PTA Balloon Dilatation Catheter OTW 014 does not state its MRI safety status. Check the labeling before MRI.
Is Finesse Injectable PTA Balloon Dilatation Catheter OTW 014 FDA cleared?
Finesse Injectable PTA Balloon Dilatation Catheter OTW 014 is covered by FDA submission K230263.
How do I contact a Summa Therapeutics, LLC sales representative?
Summa Therapeutics, LLC has not listed representatives on LA Vascular yet. Visit the Summa Therapeutics, LLC 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.