510(k) K254089 ยท DQK Computer, Diagnostic, Programmable
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 (T0
| Applicant | Centerline Biomedical, Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Feb 17, 2026 |
| Received | Dec 19, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254089
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.