FDA 510(k) Applications Submitted by Abbott Medical
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K251211 |
04/18/2025 |
ViewFlexÖ Xtra ICE Catheter; ViewFlexÖ Eco Reprocessed ICE Catheter; AdvisorÖ HD Grid Mapping Catheter, Sensor EnabledÖ; AdvisorÖ HD Grid X Mapping Catheter, Sensor EnabledÖ; AgilisÖ NxT Steerable Introducer; AgilisÖ NxT Steerable Introducer Dual-ReachÖ |
Abbott Medical |
| K242016 |
07/10/2024 |
EnSiteÖ X EP System |
Abbott Medical |
| 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 |
| K240997 |
04/11/2024 |
Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire |
Abbott Medical |
| K192267 |
08/21/2019 |
ILUMIEN System with AptiVue Software version D.3 |
Abbott Medical |
| K234118 |
12/28/2023 |
CentriMagÖ Acute Circulatory Support System |
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 |
| K242841 |
09/19/2024 |
Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) |
Abbott Medical |
| K220340 |
02/07/2022 |
Amplatzer Steerable Delivery Sheath |
Abbott Medical |
| K243549 |
11/15/2024 |
JETi Hydrodynamic Thrombectomy System |
Abbott Medical |
| K221750 |
06/16/2022 |
CPS AIM Universal II Slittable Inner Catheter |
Abbott Medical |
| K250552 |
02/25/2025 |
Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire |
Abbott Medical |
| K241538 |
05/30/2024 |
TriClip Steerable Guide 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 |
| K243493 |
11/12/2024 |
Agilis NxT Steerable Introducer Dual-Reach |
Abbott Medical |
| K220243 |
01/28/2022 |
Ultiri Measurement System |
Abbott Medical |
| K251231 |
04/22/2025 |
ViewFlexÖ X ICE Catheter, Sensor EnabledÖ |
Abbott Medical |
| K230286 |
02/02/2023 |
Assert-IQÖ Insertable Cardiac Monitor |
Abbott Medical |
| K232458 |
08/15/2023 |
JETiÖHydrodynamic Thrombectomy System |
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 |
| K250426 |
02/14/2025 |
AmuletÖ Steerable Delivery Sheath |
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 |
| K241372 |
05/15/2024 |
AdvisorÖ HD Grid X Mapping Catheter, Sensor EnabledÖ |
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 |
| K243224 |
10/07/2024 |
MitraClipÖ G5 Steerable Guide Catheter (SGC0801); TriClipÖ G5 Steerable Guide Catheter (TSGC0801) |
Abbott Medical |
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