510(k) K242133 · DQK Computer, Diagnostic, Programmable
Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle)
| Applicant | Centerline Biomedical, Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Oct 11, 2024 |
| Received | Jul 22, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K242133
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2025 | Centerline Biomedical Inc Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter Open, Classified |
DQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.