510(k) K212061
- Device
- EnSite X EP System
- Applicant
- Abbott
- 510(k) number
- K212061
- Product code
- DQK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-10-22
- Date received
- 2021-07-01
- Regulation
- 870.1425
- Classification name
- Computer, Diagnostic, Programmable
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jamie Glaser
- Address
- One St. Jude Medical Dr. St. Paul MN US 55117 55117
FDA Registration Numbers#
- 3007603826
- 1054713
- 3022451073
- 3012619193
- 3017401510
- 3033959233
- 3016674095
- 8030978
- 3020036682
- 3001592626
- 3016678045
- 3011353843
- 2124215
- 3043479346
- 3012268816
- 2246552
- 2024168
- 3012528160
- 2133810
- 3004977335
- 3021769057
- 2183744
- 3008717264
- 3014271754
- 3013557562
- 3013627970
- 3002672225
- 3007208829
- 3010342616
- 1018233
- 3010390468
- 3012027770
- 3004016520
- 2182208
- 3008729547
- 9710602
- 1064858
- 2183926
- 3009443693
- 3009600098
- 3026523691
- 3012032144
- 3012552532
- 3003768277
- 3003616071
- 3017060084
- 3004091615
- 3033300766
- 1928237
- 3008452825
- 2134213
- 3008012314
- 3008203003
- 3026740087
- 2648045
- 1650907
- 3008363989
- 3012154226
- 2126666
- 2030404
- 3014848734
- 3009499478
- 1000165971
- 2029275
- 3018783526
- 3017233611
- 3009831876
- 3017840980
- 3008329188
- 3013500228
- 3013581838
- 3012811961
- 3015151147
- 3001763079
- 1058031
- 1316463
- 3012179728
- 3004594159
- 3004972322
- 9615817
Source Documents#
Other 510(k) Records For Product Code DQK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K263016 | Intra-Operative Positioning System (IOPS) and IOPS Visionary System | Centerline Biomedical | 2026-10-01 |
| K261729 | EnSite™ X EP System | Abbott Medical | 2026-09-17 |
| K253692 | AVVIGO™+ Multi-Modality Guidance System | Boston Scientific | 2026-08-21 |
| K262005 | Affera Integrated Mapping System | Medtronic, Inc. | 2026-08-21 |
| K253576 | CorVista System® with PCWP Add-On | Analytics For Life, Inc. | 2026-07-26 |
| K262006 | EnSite™ X EP System | Abbott Medical | 2026-07-15 |
| K252978 | ScioCardio ECG Analysis Platform | Synergen Technology Labs, LLC | 2026-07-09 |
| K253463 | ILR ECG Analyzer (IM007) | Implicity, Inc. | 2026-07-02 |
| K261119 | NorthStar Mapping System (MAP01 or MAP01-01) | Imricor Medical Systems, Inc. | 2026-06-30 |
| K253088 | OneStim-DUO Cardiac Stimulator (MP5003-4CO) | Micropace Pty, Ltd. | 2026-06-12 |
| K261329 | Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS Viewpoint Simple Curve Catheter, 125cm (C01251);IOPS Viewpoint Double Curve Catheter, 75cm (C00752);IOPS Viewpoint Double Curve Catheter, 125cm (C02152);IOPS Guidewire 2 (ATW-2);IOPS Fiducial Tracking Pad (T02111);IOPS Guidewire Handle (H01035) | Centerline Biomedical | 2026-06-10 |
| K252859 | ZEUS Platform (FG0501US) | iRhythm Technologies, Inc. | 2026-05-29 |
| K260212 | EnSite™ X EP System | ABBOTT MEDICAL | 2026-04-20 |
| K253861 | ACORYS MAPPING SYSTEM | Corify Care S.L | 2026-04-13 |
| K253473 | Synchrony | Stereotaxis, Inc. | 2026-04-01 |
Legacy Summary#
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FDA Review#
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