510(k) K260212
- Device
- EnSite X EP System
- Applicant
- ABBOTT MEDICAL
- 510(k) number
- K260212
- Product code
- DQK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-04-20
- Date received
- 2026-01-23
- 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
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Christine Kim
- Address
- One St. Jude Medical Dr. St. Paul MN US 55117 55117
FDA Registration Numbers
- 2184149
- 3005877899
- 9710602
- 1218950
- 3007603855
- 3032109181
- 3013627970
- 3001592626
- 1054713
- 3004972322
- 3010342616
- 3012811961
- 2183744
- 3016701404
- 3006087789
- 3009077524
- 3017401510
- 2134265
- 3009092139
- 3012268816
- 3017060084
- 3014271754
- 2183715
- 3012520654
- 3018783526
- 3010390468
- 3013557562
- 2024168
- 9617277
- 2246552
- 2133772
- 1319660
- 2031044
- 3022780114
- 3021016555
- 3030125003
- 2183926
- 3007770164
- 3007184699
- 1064858
- 3017233611
- 2126666
- 3018940143
- 3017840980
- 1018233
- 9615102
- 3003084417
- 3005334138
- 3017638059
- 3010157426
- 3000279201
- 3009254201
- 3020036682
- 3016406615
- 3007734888
- 3008729547
- 3030721635
- 3013679558
- 1058584
- 3016618143
- 9615817
- 3015151147
- 3010705768
- 3002672225
- 3007603826
- 3003768277
- 3013300026
- 3014848734
- 3012528160
- 3022451073
- 3000976525
- 3014128039
- 3008363989
- 1928237
- 3033959233
- 3004016520
- 2133641
- 9611295
- 3004091615
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code DQK
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253861 | ACORYS MAPPING SYSTEM | Corify Care S.L | 2026-04-13 |
| K253473 | Synchrony | Stereotaxis, Inc. | 2026-04-01 |
| K253186 | HemoSphere Nano Monitor (HSNANO1) | Edwards Lifesciences, LLC | 2026-02-24 |
| K252972 | CARTO 3 EP Navigation System V8.4 | Biosense Webster, Inc. | 2026-02-20 |
| K254089 | IOPS Visionary System (MC-3); 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, Inc. | 2026-02-17 |
| K251591 | Holter ECG and ABP system (HolterABP) | Edan Instruments, Inc. | 2026-02-09 |
| K251218 | SafeBeat Rx App | SafeBeat Rx, Inc. | 2026-02-06 |
| K252164 | NorthStar Mapping System | Imricor Medical Systems | 2026-01-28 |
| K254085 | CARTO 3 EP Navigation System V9.0 with PIU Plus | Biosense Webster, Inc. | 2026-01-18 |
| K253733 | STAR Apollo Mapping System | Rhythm AI, Ltd. | 2025-12-19 |
| K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) | Edwards Lifesciences | 2025-12-18 |
| K253141 | DeepRhythmAI | Medicalgorithmics S.A. | 2025-12-11 |
| K252429 | Vektor Computational ECG Mapping System (vMap®) | Vektor Medical, Inc. | 2025-12-04 |
| K252238 | CoroFlow Cardiovascular System | Coroventis Research AB | 2025-10-24 |
| K252645 | LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub | Philips Medical Systems Nederland B.V. | 2025-10-24 |