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Centerline Biomedical, Inc.

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories1
Latest FDA decision2026-02-17
TypeNumberDevice NameCodeDateActions
510(k) K254089 IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035)DQK2026-02-17 View
510(k) K243842 Intra-Operative Positioning System (IOPS®)DQK2025-03-06 View
510(k) K242133 Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle)DQK2024-10-11 View
510(k) K241243 Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters)DQK2024-07-24 View
510(k) K230309 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)DQK2023-06-21 View
510(k) K190106 Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire HandleDQK2019-06-24 View
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