Verge Medical, Inc. · Class II · Cleared Apr 2, 2026
| K-number | K254022 |
| Device name | FLASH Flex Aorto-Ostial Angioplasty System |
| Applicant | Verge Medical, Inc. |
| Product code | LOX |
| Device class | Class II |
| Decision date | Apr 2, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.5100 |
The FLASH Flex Aorto-Ostial Angioplasty System is a rapid exchange dual balloon catheter used to expand balloon-expandable stents in coronary arteries after stent delivery. It is compatible with 0.014-inch guidewires and 6 French guide catheters, and includes a pressure relief feature to prevent over-pressurization of the proximal balloon.
The device adds enhanced tip flexibility, improved catheter trackability, FluorosaverTM markers to reduce radiation exposure, and simplified device preparation compared to the predicate. Sterilization method changed from E-beam to ethylene oxide (EO). It offers a new 5.0mm balloon size option and lower rated balloon pressures (16 ATM vs. 20 ATM for most sizes).
Not stated in this summary. The document references ISO 13485 for quality management system requirements and mentions GLP compliance for biocompatibility testing per 21 CFR Part 58, but does not cite specific consensus standards used for bench testing.
The FLASH Flex is substantially equivalent because it has identical principle of operation, same intended use for post-delivery stent expansion, compatible guidewire and catheter sizes, similar materials, and identical or comparable performance specifications. Comprehensive bench testing (tensile, burst, fatigue, etc.) and biocompatibility testing demonstrated the device functions as intended and meets pre-defined acceptance criteria equivalent to the predicate FLASH Mini Ostial System.
View the full FDA submission: accessdata.fda.gov