Angioplasty balloons
FLASH Ostial System OTW
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 FLASH Ostial System OTW
We do not have contact details for Verge Medical, Inc. yet. Send a request and we will route it to the right person for your country.
FLASH Ostial System OTW 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 |
|---|---|---|---|
| OTW6012BA | — | Not stated | Available |
| OTW7012BA | — | Not stated | Available |
| OTW7017BA | — | Not stated | Available |
FDA clearances
- 510(k) K150946 May 2015
Procedures that use angioplasty balloons
Frequently asked questions
What is FLASH Ostial System OTW 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 FLASH Ostial System OTW?
FLASH Ostial System OTW is made by Verge Medical, Inc.. It is listed under peripheral angioplasty balloons in our device library.
What sizes does FLASH Ostial System OTW come in?
The FDA device database does not list sizes for FLASH Ostial System OTW. Check the instructions for use or ask a Verge Medical, Inc. representative.
Is FLASH Ostial System OTW MRI safe?
The FDA device database entry for FLASH Ostial System OTW does not state its MRI safety status. Check the labeling before MRI.
Is FLASH Ostial System OTW FDA cleared?
FLASH Ostial System OTW is covered by FDA submission K150946.
How do I contact a Verge Medical, Inc. sales representative?
Verge Medical, Inc. has not listed representatives on LA Vascular yet. Visit the Verge 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.