Embolic protection
Vanguard
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.
Vanguard 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 |
|---|---|---|---|
| 5080x135 | — | Not stated | Available |
| 5120x135 | — | Not stated | Available |
| 5200x135 | — | MR Conditional | Available |
| 6080x135 | — | Not stated | Available |
| 6120x135 | — | MR Conditional | Available |
| 6200x135 | — | Not stated | Available |
FDA clearances
- 510(k) K181529 December 2018
Procedures that use embolic protection
Frequently asked questions
What is Vanguard 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 Vanguard?
Vanguard is made by Contego Medical, Inc.. It is listed under embolic protection devices in our device library.
What sizes does Vanguard come in?
The FDA device database does not list sizes for Vanguard. Check the instructions for use or ask a Contego Medical, Inc. representative.
Is Vanguard MRI safe?
The FDA device database entry for Vanguard does not state its MRI safety status. Check the labeling before MRI.
Is Vanguard FDA cleared?
Vanguard is covered by FDA submission K181529.
How do I contact a Contego Medical, Inc. sales representative?
Contego Medical, Inc. has not listed representatives on LA Vascular yet. Visit the Contego Medical, 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.