(53 days)
The PeriPro™ Patch is indicated for cardiac and vascular reconstruction and repair. This may include intra-cardiac patching and peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda and tibial arteries and arteriovenous access revisions.
Not Found
I am sorry, but the provided text from the FDA 510(k) K052416 document for the PeriPro™ Patch does not contain any information regarding the acceptance criteria, device performance, sample sizes for testing or training, expert qualifications, or study methodologies that you have requested.
The document is a clearance letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory compliance requirements for the manufacturer. It specifies the product's indications for use but does not detail the studies conducted to establish its safety and effectiveness or how specific performance criteria were met.
Therefore, I cannot provide the requested table and information based on the text provided.
§ 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).