FDA clears Ascent reprocessed EP catheters, cables
Ascent Healthcare Solutions has received 510(k) clearance from the FDA to reprocess the full line of IBI diagnostic electrophysiology (EP) catheters and cables, originally manufactured by Irvine Biomedical, a St. Jude company.
The catheters and cables include the Inquiry Fixed and Steerable, AFocus, AFocus II and Optima product families that offer a selection and variety of curve designs for varying anatomies, according to the Phoenix-based company.
Ascent said it focuses on reprocessing high-cost, high-volume devices, such as diagnostic EP catheters, to help its hospital partners allocate resources.
The catheters and cables include the Inquiry Fixed and Steerable, AFocus, AFocus II and Optima product families that offer a selection and variety of curve designs for varying anatomies, according to the Phoenix-based company.
Ascent said it focuses on reprocessing high-cost, high-volume devices, such as diagnostic EP catheters, to help its hospital partners allocate resources.