510(k) K211546
- Device
- Vektor Computational ECG Mapping System (vMap)
- Applicant
- Vektor Medical, Inc.
- 510(k) number
- K211546
- Product code
- DQK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-11-09
- Date received
- 2021-05-19
- 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
- Mike Monko
- Address
- 7875 Sitio Abeto Carlsbad CA US 92009 92009
FDA Registration Numbers#
- 3017401510
- 3033959233
- 3006082230
- 8022257
- 3022435840
- 3004006614
- 2134213
- 3016678045
- 1650907
- 9615817
- 3042175841
- 3031786139
- 3008329188
- 3017684005
- 3033558564
- 3026523691
- 3010089768
- 1651104
- 1219324
- 3000279201
- 2133810
- 3012528160
- 2126666
- 3008717264
- 3008012314
- 2031044
- 1058584
- 3008363989
- 3013943846
- 2135338
- 3014128039
- 1054713
- 1000165971
- 9673241
- 9617277
- 3003084417
- 2648045
- 3016701404
- 1319660
- 3009254201
- 3012154226
- 3004977335
- 3005210579
- 3008483389
- 1058031
- 2134265
- 3013500228
- 3012027770
- 3018783526
- 3006087789
- 3007603826
- 3007184699
- 3007770164
- 3000126629
- 3013627970
- 2246552
- 2030404
- 3007734888
- 3017060084
- 3007603855
- 3009831876
- 3010705768
- 3032109181
- 3005334138
- 3021769057
- 3014848734
- 3017845286
- 3013300026
- 3007208829
- 2183164
- 3022451073
- 3030125003
- 3026740087
- 3023272766
- 3012268816
- 1928237
- 3017638059
- 3012260771
- 3003616071
Source Documents#
Other 510(k) Records For Product Code DQK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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