ClearanceBrief
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

ApplicantCenterline Biomedical, Warrensville Heights OH, US
DecisionSubstantially Equivalent, Jun 10, 2026
ReceivedApr 22, 2026
TypeSpecial
FDA recordOpen 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.