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The FLASH Mini Ostial System is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion. The FLASH Mini Ostial System is also indicated for the post delivery expansion of balloon expandable stents within the coronary vasculature.

The FLASH Mini Ostial System is a .014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring and a working length of 135cm. The FLASH Mini Ostial System uses a dual balloon design that features a compliant anchoring balloon, which prevents distal migration of the balloon during angioplasty. The second semicompliant higher-pressure balloon allows for luminal dilatation of de novo lesions and post deployment stent expansion.

The provided text describes a 510(k) premarket notification for the FLASH Mini Ostial System, a PTCA Catheter. The document focuses on demonstrating substantial equivalence to a predicate device through performance data and biocompatibility testing. It does not include details about a study evaluating a device's performance against acceptance criteria using a test set, expert ground truth, or human readers, as would be common for AI/ML-based medical devices.

Therefore, many of the requested categories are not applicable to the information provided in this document.

Here's a breakdown of what can be extracted based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document states: "All test results demonstrate that the FLASH Mini Ostial System meets the established product specifications." and "All test results demonstrated that the FLASH Mini Ostial System meets all predetermined design verification and validation acceptance criteria necessary to verify safe and consistent performance of the device for its Indications for Use."

However, the specific quantitative acceptance criteria (e.g., "Balloon Crossing Profile must be

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