(30 days)
The PercuSurge GuardWire Plus Temporary Occlusion & Aspiration System is indicated for use in the coronary saphenous vein bypass grafts to:
- Contain and aspirate embolic material (thrombus/debris) while performing . Somain and aspenary angioplasty or stenting procedures.
- To subselectively infuse/deliver diagnostic or therapeutic agents with or . without vessel occlusion.
- · The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the PercuSurge GuardWire Plus Temporary Occlusion and Aspiration System. This document does not contain information regarding acceptance criteria for a device, nor does it detail a study proving the device meets said criteria.
The letter only states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices for the indicated uses. It outlines the regulatory classification and general controls.
Therefore, I cannot provide the requested information based on the input text. The information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not present in this document.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).