(50 days)
The CHASE Cardiovascular Patch Kit is indicated for cardiac and vascular patch grafting.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "Chase Cardiovascular Patch Kit." It indicates that the device has been found substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information regarding acceptance criteria, study details, or performance data for the Chase Cardiovascular Patch Kit. Therefore, I cannot generate the requested table and detailed information based on the input.
This type of FDA letter typically confirms that a device has passed the regulatory hurdle of substantial equivalence, but it does not usually include the technical performance data or specific study results used to demonstrate that equivalence. Those details would normally be found in the 510(k) submission itself, which is not provided here.
§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).