RAP Femoral Venous Cannulae

The RAP Femoral Arterial Cannulae are single-use, sterile medical devices designed for venous drainage during cardiopulmonary bypass procedures, with a maximum intended use duration of six hours. The device consists of a PVC polymer tube with wire reinforcement in distal sections, perforated holes for fluid flow, and a malleable obturator that facilitates placement along the femoral vein to the vena cava.

The modified RAP femoral arterial cannulae maintain the same fundamental technological characteristics and principles of operation as the predicate unmodified RAP Femoral Venous cannula. The primary modification is replacement of the PVC material in the basket, body, and tip to remove diethylhexyl phthalate (DEHP) plasticizer; no other design changes were made. Both versions are ethylene oxide sterilized with a non-pyrogenic fluid path.

Not stated in this summary. The document references testing in accordance with national and international standards but does not cite specific standard designations such as ISO, IEC, or ASTM numbers.

Substantial equivalence is supported by identical intended use (venous drainage during CPB up to six hours), equivalent technological characteristics and control mechanisms, and comprehensive non-clinical testing showing the modified device passes all verification, validation, and biocompatibility tests. The predicate device (K052081) has been on the market for several years with proven safety and efficacy; since the subject device differs only in DEHP removal—a material substitution not affecting function—and all performance testing is equivalent, no new safety or effectiveness questions are raised.