FDA 510(k) Applications Submitted by Amanda Shade

FDA 510(k) Number Submission Date Device Name Applicant
K230309 02/03/2023 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) Centerline Biomedical, Inc.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact