510(k) K230309 · DQK Computer, Diagnostic, Programmable
Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1)
| Applicant | Centerline Biomedical, Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Jun 21, 2023 |
| Received | Feb 3, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K230309
| 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.