(105 days)
The AngioJet XPEEDIOR 120 Rheolytic Thrombectomy Catheter is intended for use with the AngioJet System in breaking apart and removing thrombus from:
- infra-inguinal peripheral arteries ≥ 3.0 mm in diameter, ●
- upper extremity peripheral veins > 3.0 mm in diameter and .
- ilcofemoral and lower extremity veins ≥ 3.0 mm in diameter. .
When used with the AngioJet System, the XPEEDIOR Rheolytic Thrombectomy Catheter uses high velocity saline jets to percutaneously break-up and remove thrombus. These saline jets are contained within the Catheter and provide the suction that produces this effect.
This document is a 510(k) summary for the XPEEDIOR Rheolytic Thrombectomy Catheter (K071336). It doesn't contain information about acceptance criteria or a study proving that a device meets those criteria. Instead, it details an expanded indication for use for an already cleared device, stating that no design, packaging, sterilization, or other device changes were required for this expansion. It also mentions that "Applicable preclinical and clinical experience support the expanded indications for use," but does not provide details of such studies, acceptance criteria, or performance data.
Therefore, I cannot provide the requested table or answer most of the questions based on the provided text.
§ 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).