(86 days)
The Alligator Retrieval Device (ARD) is indicated for the use in retrieval of foreign objects in peripheral and neuro vasculature.
The Alligator Retrieval Device (ARD) is a retriever with grasping jaws attached to the tip of a flexible wire. The device is designed to be used in conjunction with off-the-shelf 0.21 in. (0.51mm) ID (inner diameter) microcatheter. The grasping jaws and the distal end of the ARD device are made of radio opaque material facilitating fluoroscope visualization. The ARD is for single use only.
The provided text describes a 510(k) summary for the Alligator™ Retrieval Device (ARD) and its comparison to predicate devices, but it does not contain information about acceptance criteria, device performance studies, or the specifics of such studies.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the given input. The document focuses on demonstrating substantial equivalence to predicate devices, material safety (biocompatibility), and basic performance attributes like weld strength and force-to-open, without outlining clinical or a specific performance study with defined acceptance criteria.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).