(88 days)
The coaxial dilator is used for percutaneous introduction of 0.035 inch or 0.038 inch guide wires into the vascular system following a small 21 Ga. needle stick.
The coaxial dilator set consists of an inner, tapered dilator with a slightly shorter outer dilator.
This document is a 510(k) premarket notification for a Coaxial Dilator Set. It is not a study demonstrating the performance of an AI/ML device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, or AI-specific metrics.
The document discusses substantial equivalence to predicate devices, packaging, sterilization, and general safety and effectiveness for a medical device that assists in introducing guidewires into the vascular system. It does not involve any AI/ML components or performance metrics that would require the establishment of ground truth by experts or comparative effectiveness studies.
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).