Centerline Biomedical Inc
FDA Regulatory Profile
Summary
- Total Recalls
- 1 (1 Class I)
- 510(k) Clearances
- 6
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1760-2025 | Class I | Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculat | April 11, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K254089 | IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Si | February 17, 2026 |
| K243842 | Intra-Operative Positioning System (IOPS®) | March 6, 2025 |
| K242133 | Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning Syst | October 11, 2024 |
| K241243 | Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Posit | July 24, 2024 |
| K230309 | Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Rever | June 21, 2023 |
| K190106 | Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guide | June 24, 2019 |