FDA 510(k) Applications Submitted by Alyssa Timmers
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K201148 |
04/29/2020 |
EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License |
Abbott Medical |
| K241370 |
05/14/2024 |
AgilisÖ NxT Steerable Introducer Dual-ReachÖ (I-V2-MED) |
Abbott Medical |
| K231415 |
05/16/2023 |
EnSiteÖ X EP System |
Abbott Medical |
| K202066 |
07/27/2020 |
EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled |
Abbott Medical |
| K223094 |
09/30/2022 |
EnSiteÖ X EP System TactiFlexÖ Ablation Catheter, Sensor EnabledÖ, Software Upgrade; EnSiteÖ X EP System TactiFlexÖ Ablation Catheter, Sensor EnabledÖ, Software License |
Abbott Medical |
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