Drug-coated balloons
SurVeil DCB
A sterile, 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, and to simultaneously release a drug intended to inhibit restenosis; 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. This is a single-use device.
SurVeil DCB 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 |
|---|---|---|---|
| SRV03513504010 | Balloon Diameter 4 mm; Balloon Length 100 mm; Catheter Length 135 cm | Not stated | Available |
| SRV03513504012 | Balloon Diameter 4 mm; Balloon Length 120 mm; Catheter Length 135 cm | Not stated | Available |
| SRV03513504015 | Balloon Diameter 4 mm; Balloon Length 150 mm; Catheter Length 135 cm | Not stated | Available |
| SRV03513504040 | Balloon Diameter 4 mm; Balloon Length 40 mm; Catheter Length 135 cm | Not stated | Available |
| SRV03513504060 | Balloon Diameter 4 mm; Balloon Length 40 mm; Catheter Length 135 cm | Not stated | Available |
| SRV03513504080 | Balloon Diameter 4 mm; Balloon Length 80 mm; Catheter Length 135 cm | Not stated | Available |
| SRV03513505010 | Balloon Diameter 5 mm; Balloon Length 100 mm; Catheter Length 135 cm | Not stated | Available |
| SRV03513505012 | Balloon Diameter 5 mm; Balloon Length 120 mm; Catheter Length 135 cm | Not stated | Available |
| SRV03513505015 | Balloon Diameter 5 mm; Balloon Diameter 150 mm; Catheter Length 135 cm | Not stated | Available |
| SRV03513505040 | Balloon Diameter 5 mm; Balloon Length 40 mm; Catheter Length 135 cm | Not stated | Available |
| SRV03513505060 | Balloon Diameter 5 mm; Balloon Length 60 mm; Catheter Length 135 cm | Not stated | Available |
| SRV03513505080 | Balloon Diameter 5 mm; Balloon Length 80 mm; Catheter Length 135 cm | Not stated | Available |
| SRV03513506010 | Balloon Diameter 6 mm; Balloon Length 100 mm; Catheter Length 135 cm | Not stated | Available |
| SRV03513506012 | Balloon Diameter 6 mm; Balloon Length 120 mm; Catheter Length 135 cm | Not stated | Available |
| SRV03513506015 | Balloon Diameter 6 mm; Balloon Length 150 mm; Catheter Length 135 cm | Not stated | Available |
| SRV03513506040 | Balloon Diameter 6 mm; Balloon Length 40 mm; Catheter Length 135 cm | Not stated | Available |
| SRV03513506060 | Balloon Diameter 6 mm; Balloon Length 60 mm; Catheter Length 135 cm | Not stated | Available |
| SRV03513506080 | Balloon Diameter 6 mm; Balloon Length 80 mm; Catheter Length 135 cm | Not stated | Available |
| SRV03513507010 | Balloon Diameter 7 mm; Balloon Length 100 mm; Catheter Length 135 cm | Not stated | Available |
| SRV03513507040 | Balloon Diameter 7 mm; Balloon Length 40 mm; Catheter Length 135 cm | Not stated | Available |
| SRV03513507060 | Balloon Diameter 7 mm; Balloon Length 60 mm; Catheter Length 135 cm | Not stated | Available |
| SRV03513507080 | Balloon Diameter 7 mm; Balloon Length 80 mm; Catheter Length 135 cm | Not stated | Available |
FDA clearances
- PMA P210025 December 2024
Procedures that use drug-coated balloons
Frequently asked questions
What is SurVeil DCB used for?
A sterile, 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, and to simultaneously release a drug intended to inhibit restenosis; 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. This is a single-use device.
Who makes SurVeil DCB?
SurVeil DCB is made by Surmodics, Inc.. It is listed under drug-coated balloons in our device library.
What sizes does SurVeil DCB come in?
Sizes listed for SurVeil DCB: Balloon Diameter: 4–150 mm; Catheter Length: 135 cm; Balloon Length: 40–150 mm. Confirm availability with the manufacturer's instructions for use.
Is SurVeil DCB MRI safe?
The FDA device database entry for SurVeil DCB does not state its MRI safety status. Check the labeling before MRI.
Is SurVeil DCB FDA cleared?
SurVeil DCB is covered by FDA submission P210025.
How do I contact a Surmodics, Inc. sales representative?
Surmodics, Inc. has not listed representatives on LA Vascular yet. Visit the Surmodics, 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.