(87 days)
The TorFlex Transseptal Guiding Sheath is indicated for the percutaneous introduction of various devices into heart chambers, including the left atrium via transseptal puncture/perforation.
TorFlex Transseptal Guiding Sheath
The provided document is a 510(k) clearance letter from the FDA for the "TorFlex Transseptal Guiding Sheath". This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The letter states that the device is substantially equivalent to legally marketed predicate devices, which means that the device's safety and effectiveness are considered comparable to devices already on the market. However, it does not include details of specific performance criteria or a study designed to evaluate them against a set of predetermined acceptance criteria.
Therefore, I cannot provide the requested information from this document.
§ 866.5520 Immunoglobulin G (Fab fragment specific) immunological test system.
(a)
Identification. An immunoglobulin G (Fab fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Fab antigen-binding fragment resulting from breakdown of immunoglobulin G antibodies in urine, serum, and other body fluids. Measurement of Fab fragments of immunoglobulin G aids in the diagnosis of lymphoproliferative disorders, such as multiple myeloma (tumor of bone marrow cells), Waldenstrom's macroglobulinemia (increased immunoglobulin production by the spleen and bone marrow cells), and lymphoma (tumor of the lymphoid tissues).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.