Angioplasty balloons
Chocolate
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.
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 | Balloon Length 40.0 mm; Balloon Diameter 3.5 mm; Length 135.0 cm | Not stated | Available |
| CB1413535040OTW | Balloon Length 40.0 mm; Length 135.0 cm; Balloon Diameter 3.5 mm | Not stated | Available |
| CB1413535040OTW | Balloon Diameter 3.5 mm; Length 135.0 cm; Balloon Length 40.0 mm | Not stated | Available |
| CB1413535080OTW | Length 135.0 cm; Balloon Diameter 3.5 mm; Balloon Length 80.0 mm | Not stated | Available |
| CB1413535080OTW | Balloon Diameter 3.5 mm; Length 135.0 cm; Balloon Length 80.0 mm | Not stated | Available |
| CB1413535080OTW | Balloon Diameter 3.5 mm; Balloon Length 80.0 mm; Length 135.0 cm | Not stated | Available |
| CB1413535120OTW | Length 135.0 cm; Balloon Diameter 3.5 mm; Balloon Length 120.0 mm | Not stated | Available |
| CB1413535120OTW | Balloon Diameter 3.5 mm; Length 135.0 cm; Balloon Length 120.0 mm | Not stated | Available |
| CB1413535120OTW | Balloon Length 120.0 mm; Length 135.0 cm; Balloon Diameter 3.5 mm | Not stated | Available |
| CB1413540040OTW | Length 135.0 cm; Balloon Diameter 4.0 mm; Balloon Length 40.0 mm | Not stated | Available |
| CB1413540040OTW | Balloon Diameter 4.0 mm; Length 135.0 cm; Balloon Length 40.0 mm | Not stated | Available |
| CB1413540040OTW | Length 135.0 cm; Balloon Diameter 4.0 mm; 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 |
| CB1413540080OTW | Length 135.0 cm; Balloon Diameter 4.0 mm; Balloon Length 80.0 mm | Not stated | Available |
| CB1413540080OTW | Balloon Length 80.0 mm; Balloon Diameter 4.0 mm; Length 135.0 cm | Not stated | Available |
| CB1413540120OTW | Length 135.0 cm; Balloon Length 120.0 mm; Balloon Diameter 4.0 mm | Not stated | Available |
| CB1413540120OTW | Balloon Length 120.0 mm; Balloon Diameter 4.0 mm; Length 135.0 cm | Not stated | Available |
| CB1413540120OTW | Length 135.0 cm; Balloon Diameter 4.0 mm; Balloon Length 120.0 mm | Not stated | Available |
| CB1415025040OTW | Length 150.0 cm; Balloon Length 40.0 mm; Balloon Diameter 2.5 mm | Not stated | Available |
| CB1415025040OTW | Length 150.0 cm; Balloon Diameter 2.5 mm; Balloon Length 40.0 mm | Not stated | Available |
| CB1415025040OTW | Length 150.0 cm; Balloon Diameter 2.5 mm; Balloon Length 40.0 mm | Not stated | Available |
| CB1415025080OTW | Length 150.0 cm; Balloon Diameter 2.5 mm; Balloon Length 80.0 mm | Not stated | Available |
| CB1415025080OTW | Balloon Diameter 2.5 mm; Balloon Length 80.0 mm; Length 150.0 cm | Not stated | Available |
| CB1415025080OTW | Length 150.0 cm; Balloon Diameter 2.5 mm; Balloon Length 80.0 mm | Not stated | Available |
| CB1415025120OTW | Balloon Diameter 2.5 mm; Balloon Length 120.0 mm; Length 150.0 cm | Not stated | Available |
| CB1415025120OTW | Balloon Length 120.0 mm; Length 150.0 cm; Balloon Diameter 2.5 mm | Not stated | Available |
| CB1415025120OTW | Balloon Diameter 2.5 mm; Balloon Length 120.0 mm; Length 150.0 cm | Not stated | Available |
| CB1415030040OTW | Balloon Diameter 3.0 mm; Balloon Length 40.0 mm; Length 150.0 cm | Not stated | Available |
| CB1415030040OTW | Length 150.0 cm; Balloon Diameter 3.0 mm; Balloon Length 40.0 mm | Not stated | Available |
| CB1415030040OTW | Length 150.0 cm; Balloon Length 40.0 mm; Balloon Diameter 3.0 mm | Not stated | Available |
| CB1415030080OTW | Balloon Length 80.0 mm; Length 150.0 cm; Balloon Diameter 3.0 mm | Not stated | Available |
| CB1415030080OTW | Length 150.0 cm; Balloon Length 80.0 mm; Balloon Diameter 3.0 mm | Not stated | Available |
| CB1415030080OTW | Balloon Length 80.0 mm; Balloon Diameter 3.0 mm; Length 150.0 cm | Not stated | Available |
| CB1415030120OTW | Length 150.0 cm; Balloon Diameter 3.0 mm; Balloon Length 120.0 mm | Not stated | Available |
| CB1415030120OTW | Length 150.0 cm; Balloon Length 120.0 mm; Balloon Diameter 3.0 mm | Not stated | Available |
| CB1415030120OTW | Balloon Length 120.0 mm; Balloon Diameter 3.0 mm; Length 150.0 cm | Not stated | Available |
| CB1812050040OTW | Length 120.0 cm; Balloon Length 40.0 mm; Balloon Diameter 5.0 mm | Not stated | Available |
| CB1812050040OTW | Balloon Length 40.0 mm; Length 120.0 cm; Balloon Diameter 5.0 mm | Not stated | Available |
| CB1812050040OTW | Balloon Diameter 5.0 mm; Balloon Length 40.0 mm; Length 120.0 cm | Not stated | Available |
| CB1812050080OTW | Balloon Length 80.0 mm; Length 120.0 cm; Balloon Diameter 5.0 mm | Not stated | Available |
| CB1812050080OTW | Balloon Length 80.0 mm; Balloon Diameter 5.0 mm; Length 120.0 cm | Not stated | Available |
| CB1812050080OTW | Balloon Diameter 5.0 mm; Balloon Length 80.0 mm; Length 120.0 cm | Not stated | Available |
| CB1812050120OTW | Length 120.0 cm; Balloon Diameter 5.0 mm; Balloon Length 120.0 mm | Not stated | Available |
| CB1812050120OTW | Balloon Diameter 5.0 mm; Balloon Length 120.0 mm; Length 120.0 cm | Not stated | Available |
| CB1812050120OTW | Balloon Length 120.0 mm; Length 120.0 cm; Balloon Diameter 5.0 mm | Not stated | Available |
| CB1812060040OTW | Balloon Length 40.0 mm; Balloon Diameter 6.0 mm; Length 120.0 cm | Not stated | Available |
| CB1812060040OTW | Balloon Diameter 6.0 mm; Balloon Length 40.0 mm; Length 120.0 cm | Not stated | Available |
| CB1812060040OTW | Balloon Diameter 6.0 mm; Length 120.0 cm; Balloon Length 40.0 mm | Not stated | Available |
| CB1812060080OTW | Length 120.0 cm; Balloon Diameter 6.0 mm; Balloon Length 80.0 mm | Not stated | Available |
| CB1812060080OTW | Length 120.0 cm; Balloon Diameter 6.0 mm; Balloon Length 80.0 mm | Not stated | Available |
| CB1812060080OTW | Length 120.0 cm; Balloon Diameter 6.0 mm; Balloon Length 80.0 mm | Not stated | Available |
| CB1812060120OTW | Balloon Diameter 6.0 mm; Length 120.0 cm; Balloon Length 120.0 mm | Not stated | Available |
| CB1812060120OTW | Balloon Length 120.0 mm; Balloon Diameter 6.0 mm; Length 120.0 cm | Not stated | Available |
| CB1812060120OTW | Balloon Diameter 6.0 mm; Balloon Length 120.0 mm; Length 120.0 cm | Not stated | Available |
FDA clearances
- 510(k) K213631 December 2021
- 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 Medtronic, Inc.. It is listed under peripheral angioplasty balloons in our device library.
What sizes does Chocolate come in?
Sizes listed for Chocolate: Length: 120–150 cm; Balloon Diameter: 2.5–6 mm; Balloon Length: 40–120 mm. 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 submissions K130414, K213631.
How do I contact a Medtronic, Inc. sales representative?
Medtronic, Inc. has not listed representatives on LA Vascular yet. Visit the Medtronic, 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.