Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1)

Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1) is an FDA 510(k)-cleared medical device (K230309) manufactured by Centerline Biomedical, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 20, 2023. Regulation: 8.