FDA 510(k) Applications Submitted by Abbott Medical
| 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 |
| 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 |
| K192267 |
08/21/2019 |
ILUMIEN System with AptiVue Software version D.3 |
Abbott Medical |
| K211989 |
06/28/2021 |
Aveir Introducer |
Abbott Medical |
| K213494 |
11/01/2021 |
Aveir Retrieval Catheter |
Abbott Medical |
| K201181 |
04/30/2020 |
EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System |
Abbott Medical |
| K230283 |
02/01/2023 |
Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 405144, 405145, 405146, 405147, 405149, 405153, 405154, 405254, 405269, 405270, 405404, 405408, 405412, 405416, 405418, 405420, 405422, 4 |
Abbott Medical |
| K221397 |
05/13/2022 |
MitraClip G4 Steerable Guide Catheter |
Abbott Medical |
| K212026 |
06/29/2021 |
Amplatzer Steerable Delivery Sheath |
Abbott Medical |
| K232690 |
09/01/2023 |
AmuletÖ Steerable Delivery Sheath |
Abbott Medical |
| K212738 |
08/30/2021 |
Amplatzer Talisman Delivery Sheath |
Abbott Medical |
| K230411 |
02/15/2023 |
Dragonfly OpStarÖ Imaging Catheter |
Abbott Medical |
| K232386 |
08/09/2023 |
ILUMIENÖ OPTISÖ System, OPTISÖ Integrated System, OPTISÖ Mobile System, with AptiVueÖ Imaging Software version E.6 |
Abbott Medical |
| K220340 |
02/07/2022 |
Amplatzer Steerable Delivery Sheath |
Abbott Medical |
| K221750 |
06/16/2022 |
CPS AIM Universal II Slittable Inner Catheter |
Abbott Medical |
| K201610 |
06/15/2020 |
IonicRF Generator |
Abbott Medical |
| K203293 |
11/09/2020 |
Abbott Medical Grounding Pad, model RF-DGP-IS |
Abbott Medical |
| K220243 |
01/28/2022 |
Ultiri Measurement System |
Abbott Medical |
| K230286 |
02/02/2023 |
Assert-IQÖ Insertable Cardiac Monitor |
Abbott Medical |
| K231311 |
05/05/2023 |
CPS DirectÖ Universal slittable outer guide catheter (DS2C029) |
Abbott Medical |
| K190581 |
03/06/2019 |
Amplatzer Trevisio Intravascular Delivery System |
Abbott Medical |
| K231588 |
06/01/2023 |
ViewFlexÖ Eco Reprocessed ICE Catheter |
Abbott Medical |
| K230934 |
04/03/2023 |
ViewFlexÖ Eco Reprocessed ICE Catheter |
Abbott Medical |
| K222217 |
07/25/2022 |
ViewFlex Xtra Reprocessed ICE Catheter |
Abbott Medical |
| K192019 |
07/29/2019 |
Dragonfly OpStarÖ Imaging Catheter, AptiVueÖ Software version E.5.1 |
Abbott Medical |
| K210458 |
02/16/2021 |
OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System |
Abbott Medical |
| K213364 |
10/12/2021 |
EnSite X EP System |
Abbott Medical |
| K192037 |
07/30/2019 |
Advisor VL Circular Mapping Catheter, Sensor Enabled |
Abbott Medical |
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