Centerline Biomedical, Inc.
Medical device manufacturer in Warrensville Heights, OH.
7510(k) clearances
0PMA approvals
1recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K261329 | Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…DQK · Special | 06/10/2026SE |
| K254089 | IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS…DQK · Traditional | 02/17/2026SE |
| K243842 | Intra-Operative Positioning System (IOPS®)DQK · Traditional | 03/06/2025SE |
| K242133 | Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative…DQK · Special | 10/11/2024SE |
| K241243 | Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)…DQK · Special | 07/24/2024SE |
| K230309 | Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1)…DQK · Special | 06/21/2023SE |
| K190106 | Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter…DQK · Traditional | 06/24/2019SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1760-2025 Class I | Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate…Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate… | 04/11/2025Open, Classified |