510(k) K223094 · DQK Computer, Diagnostic, Programmable
EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software Upgrade; EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software License
| Applicant | ABBOTT MEDICAL, St. Paul MN, US |
| Decision | Substantially Equivalent, Dec 27, 2022 |
| Received | Sep 30, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223094
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.