FDA 510(k) Applications Submitted by Centerline Biomedical, Inc.

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.
K190106 01/22/2019 Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle Centerline Biomedical, Inc.


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