(126 days)
The ZelanteDVT™ Thrombectomy Set is intended for the removal of thrombus from and infusion of fluids into the peripheral vasculature.
The ZelanteDVT™ Thrombectomy Set is intended for use with the AngioJet® Ultra Console to break apart and remove thrombus, including deep vein thrombus (DVT), from:
· Iliofemoral and lower extremity veins ≥ 6.0 mm in diameter and
· Upper extremity peripheral veins ≥ 6.0 mm in diameter.
The ZelanteDVT Thrombectomy Set is also intended for use with the AngioJet Ultra Power Pulse® technique for the controlled and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.
The ZelanteDVTT™ Thrombectomy Set is one component of the AngioJet® Ultra Thrombectomy System (AngioJet Ultra System). The other component, packaged and sold separately, is the multiple-use AngioJet® Ultra Console. The ZelanteDVT Thrombectomy Set can only be used in conjunction with the AngioJet Ultra Console.
The ZelanteDVT Thrombectomy Set uses high-velocity saline to create a low pressure zone at the catheter tip. Thrombus is drawn into the catheter where it is fragmented by the jets and evacuated from the body. The waste tubing transports the thrombus debris from the catheter to the waste collection bag for ultimate disposal.
The 105 cm ZelanteDVT Thrombectomy Catheter is introduced through an 8F introducer sheath and tracks and operates over a 0.035" (0.89 mm) guidewire. The manifold is equipped with a port with an attached stopcock. This port can be used to inject contrast media and other fluids into the bloodstream.
This document is a 510(k) premarket notification for the ZelanteDVT™ Thrombectomy Set. It describes the device, its intended use, and indicates its substantial equivalence to a predicate device. However, this document does not contain the detailed acceptance criteria or the specific study that proves the device meets those criteria in the format requested.
Here's an analysis of what is available and what is missing based on your request:
1. A table of acceptance criteria and the reported device performance
- Missing. The document lists various nonclinical tests performed (biocompatibility and in vitro performance tests) such as "Hemolysis Ratio", "Clot Removal", "Net Evacuation", etc., but it does not provide specific quantitative acceptance criteria (e.g., "Hemolysis Ratio
§ 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).