(324 days)
The FlexCath™ Steerable Sheath & Dilator is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.
The FlexCath™ Steerable Sheath is a deflectable catheter introducer used to facilitate placing a catheter through the skin into the artery or vein. It is comprised of the following two (2) main sections: the shaft and the handle. A dilator is also part of the package.
The provided text does not contain any information about acceptance criteria or a study proving device performance for the FlexCath™ Steerable Sheath & Dilator.
The document is a 510(k) summary, which is a premarket notification for a medical device seeking substantial equivalence to a predicate device. It primarily focuses on the device description, intended use, and a comparison of technological characteristics to predicate devices. There is no mention of clinical studies, performance endpoints, sample sizes, expert involvement, or statistical analyses that would typically be associated with proving device performance against acceptance criteria.
Therefore, I cannot populate the requested table or answer the specific questions because the information is not present in the provided text.
§ 870.1280 Steerable catheter.
(a)
Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.(b)
Classification. Class II (performance standards).