510(k) K202066
- Device
- 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
- Applicant
- Abbott Medical
- 510(k) number
- K202066
- Product code
- DQK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-11-25
- Date received
- 2020-07-27
- 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
- Alyssa Timmers
- Address
- One St. Jude Medical Dr. St. Paul MN US 55117 55117
FDA Registration Numbers#
- 3045498928
- 3037724692
- 3014271754
- 3010342616
- 3023164
- 3010288146
- 3001763079
- 3003144120
- 3013679558
- 3033558564
- 3024821700
- 3004972322
- 3012260771
- 3001570235
- 3004594159
- 2032112
- 3009499478
- 3017638059
- 3011353843
- 3003616071
- 1527715
- 3016674095
- 2133641
- 2134265
- 3000126629
- 3016406615
- 1721686
- 3009715978
- 3012268816
- 3007029079
- 3010728615
- 3012179728
- 3045323923
- 3007208829
- 1317188
- 3007137685
- 3003768277
- 3022780114
- 1650907
- 9673241
- 2126666
- 3005877899
- 3016618143
- 3030125003
- 3007734888
- 3042175841
- 2024168
- 3007184699
- 2135338
- 1000122786
- 2952596
- 8022257
- 1054713
- 3004105270
- 1316463
- 3012027770
- 9615102
- 1018233
- 3012619193
- 2031044
- 3004091615
- 3005334138
- 3008012314
- 2246552
- 2184149
- 3012359877
- 9615817
- 3032916632
- 3033959233
- 1320894
- 3009600098
- 3009077524
- 3017845286
- 2183744
- 3009831876
- 1928237
- 3009254201
- 1224919
- 3008093809
- 3017840980
Source Documents#
Other 510(k) Records For Product Code DQK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
Legacy Summary#
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FDA Review#
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