Angioplasty balloons
Chocolate
by EV3, Inc
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 Chocolate
We do not have contact details for EV3, Inc yet. Send a request and we will route it to the right person for your country.
Chocolate 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 |
|---|---|---|---|
| CB1413535040OTW | Length 135.0 cm; Balloon Diameter 3.5 mm; Balloon Length 40.0 mm | Not stated | Available |
| CB1413535080OTW | Balloon Length 80.0 mm; Length 135.0 cm; Balloon Diameter 3.5 mm | Not stated | Available |
| CB1413535120OTW | Balloon Diameter 3.5 mm; Length 135.0 cm; Balloon Length 120.0 mm | Not stated | Available |
| CB1413540040OTW | Balloon Diameter 4.0 mm; Length 135.0 cm; Balloon Length 40.0 mm | Not stated | Available |
| CB1413540080OTW | Balloon Diameter 4.0 mm; Length 135.0 cm; Balloon Length 80.0 mm | Not stated | Available |
| CB1413540120OTW | Balloon Length 120.0 mm; Length 135.0 cm; Balloon Diameter 4.0 mm | Not stated | Available |
| CB1415025040OTW | Balloon Length 40.0 mm; Balloon Diameter 2.5 mm; Length 150.0 cm | Not stated | Available |
| CB1415025080OTW | Balloon Diameter 2.5 mm; Balloon Length 80.0 mm; Length 150.0 cm | Not stated | Available |
| CB1415025120OTW | Length 150.0 cm; Balloon Diameter 2.5 mm; Balloon Length 120.0 mm | Not stated | Available |
| CB1415030040OTW | Length 150.0 cm; Balloon Length 40.0 mm; Balloon Diameter 3.0 mm | Not stated | Available |
| CB1415030080OTW | Balloon Diameter 3.0 mm; Length 150.0 cm; Balloon Length 80.0 mm | Not stated | Available |
| CB1415030120OTW | Length 150.0 cm; Balloon Length 120.0 mm; Balloon Diameter 3.0 mm | Not stated | Available |
| CB1812050040OTW | Balloon Diameter 5.0 mm; Balloon Length 40.0 mm; Length 120.0 cm | Not stated | Available |
| CB1812050080OTW | Length 120.0 cm; Balloon Diameter 5.0 mm; Balloon Length 80.0 mm | Not stated | Available |
| CB1812050120OTW | Length 120.0 cm; Balloon Diameter 5.0 mm; Balloon Length 120.0 mm | Not stated | Available |
| CB1812060040OTW | Balloon Diameter 6.0 mm; Balloon Length 40.0 mm; Length 120.0 cm | Not stated | Available |
| CB1812060080OTW | Balloon Diameter 6.0 mm; Balloon Length 80.0 mm; Length 120.0 cm | Not stated | Available |
| CB1812060120OTW | Length 120.0 cm; Balloon Diameter 6.0 mm; Balloon Length 120.0 mm | Not stated | Available |
FDA clearances
- 510(k) K130414 June 2013
Procedures that use angioplasty balloons
Frequently asked questions
What is Chocolate 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 Chocolate?
Chocolate is made by EV3, Inc. It is listed under peripheral angioplasty balloons in our device library.
What sizes does Chocolate come in?
Sizes listed for Chocolate: Balloon Diameter: 2.5–6 mm; Balloon Length: 40–120 mm; Length: 120–150 cm. Confirm availability with the manufacturer's instructions for use.
Is Chocolate MRI safe?
The FDA device database entry for Chocolate does not state its MRI safety status. Check the labeling before MRI.
Is Chocolate FDA cleared?
Chocolate is covered by FDA submission K130414.
How do I contact a EV3, Inc sales representative?
EV3, Inc has not listed representatives on LA Vascular yet. Visit the EV3, Inc 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.