510(k) K251211 · OBJ Catheter, Ultrasound, Intravascular
ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid Mapping Catheter, Sensor Enabled; Advisor HD Grid X Mapping Catheter, Sensor Enabled; Agilis NxT Steerable Introducer; Agilis NxT Steerable Introducer Dual-Reach
| Applicant | ABBOTT MEDICAL, Plymouth MN, US |
| Decision | Substantially Equivalent, May 23, 2025 |
| Received | Apr 18, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K251211
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.