Atlas FDA

EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2

FDA 510(k) clearance K183128 · decided 2018-12-12

Clearance details

K-number
K183128
Device name
EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2
Applicant
Abbott
Decision
Substantially Equivalent
Date received
2018-11-13
Decision date
2018-12-12
Days to decision
29 days
Clearance type
Special
Product code
DQK
Device class
2
Regulation number
870.1425
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
St. Paul, MN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
CorVista System® with PCWP Add-On (K253576)Analytics For Life, Inc.2026-07-26
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ScioCardio ECG Analysis Platform (K252978)Synergen Technology Labs, LLC2026-07-09
ILR ECG Analyzer (IM007) (K253463)Implicity, Inc.2026-07-02
NorthStar Mapping System (MAP01 or MAP01-01) (K261119)Imricor Medical Systems, Inc.2026-06-30
OneStim-DUO Cardiac Stimulator (MP5003-4CO) (K253088)Micropace Pty, Ltd.2026-06-12
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) (K261329)Centerline Biomedical2026-06-10
ZEUS Platform (FG0501US) (K252859)iRhythm Technologies, Inc.2026-05-29
EnSite™ X EP System (K260212)ABBOTT MEDICAL2026-04-20
ACORYS MAPPING SYSTEM (K253861)Corify Care S.L2026-04-13
Synchrony (K253473)Stereotaxis, Inc.2026-04-01
HemoSphere Nano Monitor (HSNANO1) (K253186)Edwards Lifesciences, LLC2026-02-24

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
CentriMag™ Circulatory Support System (P170038/S025)Abbott2025-12-01
CentriMag Circulatory Support System (P170038/S023)Abbott2025-09-29
CentriMag™ Circulatory Support System (P170038/S026)Abbott2025-08-21
CentriMag Circulatory Support System (P170038/S024)Abbott2025-06-02
CentriMag™ Circulatory Support System (P170038/S017)Abbott2025-02-04
CentriMag Circulatory Support System (P170038/S022)Abbott2024-11-05
CentriMag Circulatory Support System (P170038/S021)Abbott2024-11-01
CentriMag™ Circulatory Support System (P170038/S020)Abbott2024-09-25