(60 days)
The Export Aspiration Catheter is indicated for:
- Removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system, and
- To subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion.
The Export Catheter is a dual lumen catheter for use with the GuardWire Temporary Occlusion and Aspiration System. The main (continuous) lumen of the catheter is the aspiration/infusion lumen while the smaller of the lumens is the guidewire lumen. The size of the wire lumen is sized so that the Export catheter may run over a 0.14inch wire smoothly. Also, the wire lumen is designed as a single operator lumen, as such it is only present on a small section of the distal end of the catheter. The larger sized lumen is the aspiration lumen. An aspiration syringe is provided, as is an aspiration line. These are attached to the proximal end of the Export to facilitate blood and debris being evacuated from the site into the syringe.
This document is a 510(k) premarket notification for a medical device called the "Export Aspiration Catheter." It is not an AI/ML device, and therefore the requested information about acceptance criteria, study details, ground truth, and training data is not applicable.
The document describes a physical medical device and its intended use, focusing on its substantial equivalence to previously marketed predicate devices. The FDA's initial letter (June 1, 2004) and a subsequent administrative change (October 8, 2021) confirm its clearance.
§ 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).