Angioplasty balloons
FLASH Ostial System
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
Contact Verge Medical, Inc. directly; they can quote, ship, or point you to the distributor for your country.
From vergemedical.com, checked October 2026.
No reply, or outside their markets? Send us a request and we route it to a rep or distributor for your country.
FLASH Ostial System 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 |
|---|---|---|---|
| OAB6014BA | — | Not stated | Available |
| OAB6019BA | — | Not stated | Available |
| OAB7019BA | — | Not stated | Available |
| OCB4014BA | — | Not stated | Available |
| OCB5019BA | — | Not stated | Available |
FDA clearances
- 510(k) K122178 October 2012
- 510(k) K122379 September 2012
- 510(k) K113775 June 2012
- 510(k) K120738 March 2012
Procedures that use angioplasty balloons
Frequently asked questions
What is FLASH Ostial System 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?
FLASH Ostial System is made by Verge Medical, Inc.. It is listed under peripheral angioplasty balloons in our device library.
What sizes does FLASH Ostial System come in?
The FDA device database does not list sizes for FLASH Ostial System. Check the instructions for use or ask a Verge Medical, Inc. representative.
Is FLASH Ostial System MRI safe?
The FDA device database entry for FLASH Ostial System does not state its MRI safety status. Check the labeling before MRI.
Is FLASH Ostial System FDA cleared?
FLASH Ostial System is covered by FDA submissions K120738, K122379, K113775, K122178.
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.