(231 days)
The Multi-Snare Set (and its components) is intended for: Retrieval and manipulation of foreign objects from the vascular system and hollow viscera Assistance in creating loops where cross-over technique is applied Repositioning of indwelling venous catheters Assistance in performing venipuncture to obtain access to central vein
The pfm Multi-Snare Set is contains of the following parts: - Inner wire which forms the loop; - Coil mounted on the inner wire in the loop section; - Shaft body consisting of an outside coil and a core wire; and - Transition from loop wire to shaft body. The Multi-Snare Set consists of a highly elastic Nitinol wire with a pre-formed loop on its distal end. The ware of the snare's highly elastic design, the snare can be introduced through an insertion sheath. The diameter of the snare can be adjusted depending on the position of the sheath. For better manipulation and torque-ability a torquer is provided. The introducer sheath is designed for interventional insertion of instruments and systems into the vascular system. The insertion sheath consists of polyethylene tubing, which is curved at its distal end and has a luer adapter at its proximal end. For better visualization the introducer sheath has an additional distal radiopaque marker.
This document describes a 510(k) Summary of Safety and Effectiveness for the Multi-Snare Set, a medical device for retrieving foreign objects from the vascular system. However, the provided text does not contain any information regarding acceptance criteria, study design, device performance metrics, or ground truth establishment.
The document is a regulatory submission for premarket notification (510(k)) to the FDA, focusing on device description, intended use, and substantial equivalence to predicate devices. It confirms successful clearance by the FDA without detailing any specific performance studies or their results.
Therefore, I cannot fulfill your request for the detailed information as it is not present in 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).