510(k) K261329 ยท DQK Computer, Diagnostic, Programmable
Intra-Operative Positioning System (IOPS) (MC-1);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 Tr
| Applicant | Centerline Biomedical, Warrensville Heights OH, US |
| Decision | Substantially Equivalent, Jun 10, 2026 |
| Received | Apr 22, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K261329
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.