(200 days)
The Catheter Sheath Introducer is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
Not Found
The provided text is a clearance letter from the FDA for a device called "Neich Advance NM™ Catheter Sheath Introducer System." It declares the device substantially equivalent to a legally marketed predicate device.
However, this document does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria for performance metrics such as accuracy, sensitivity, specificity, or any other quantifiable measure of device performance.
The letter focuses on the regulatory clearance process, specifically substantial equivalence based on the device's indications for use. It outlines the general regulatory requirements for marketing the device.
Therefore, I cannot fulfill your request for the detailed table and study information because the provided input does not contain that kind of data.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).