(69 days)
Intended for removal of fresh, soft thrombi/emboli from the peripheral arterial system.
The Flexor Evac Aspiration Catheter is hydrophilically coated, Flexor® material with a radiopaque band. The device is supplied with a Tuohy-Borst side-arm adaptor, stopcock valve, rapid exchange dilator, and a 30 mL vacuum syringe. This device is available in various lengths and French sizes.
This document is a 510(k) premarket notification for the Cook Flexor Evac Aspiration Catheter. It does not contain information about acceptance criteria or a study proving the device meets said criteria in the format requested. The document describes the device, its intended use, and lists types of tests performed (e.g., pressure rating, liquid leakage, tensile strength, animal study, biocompatibility) to assure reliable design and performance, but it does not provide specific acceptance values or detailed results for these tests. There is no information about a multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance, ground truth establishment, or sample sizes for training or test sets in the context of an AI/ML device.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).