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#
- 3007029079
- 3030125003
- 3008717264
- 3012179728
- 2648045
- 3012359877
- 3017638059
- 3012619193
- 3032916632
- 2134265
- 3008329188
- 3007184699
- 3007734888
- 3009499478
- 3008093809
- 3013943846
- 2031044
- 3016674095
- 3022780114
- 2182208
- 1930027
- 3013403214
- 3000279201
- 3004594159
- 2183164
- 1000122786
- 2024168
- 3016678045
- 9617277
- 8022257
- 2184149
- 3003144120
- 3019388613
- 3010342616
- 3017401510
- 3010155648
- 9610816
- 2135338
- 3009254201
- 3012528160
- 3009092139
- 3008203003
- 2952596
- 3008363989
- 1224919
- 9611295
- 2133810
- 3010728615
- 3012260771
- 3004972322
- 3007603826
- 3007603855
- 3012552532
- 1054713
- 3031786139
- 3007208829
- 3003084417
- 3014271754
- 3006087789
- 3003616071
- 2032112
- 3016406615
- 3012520654
- 9615817
- 3018940143
- 9681377
- 1018233
- 3013557562
- 3012268816
- 1219324
- 1064858
- 3009077524
- 3030721635
- 1651104
- 3004105270
- 3043479346
- 3004016520
- 1928237
- 2134213
Source Documents#
Other 510(k) Records For Product Code DQK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases