Atlas FDA

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

FDA 510(k) clearance K202066 · decided 2020-11-25

Clearance details

K-number
K202066
Device name
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
Decision
Substantially Equivalent
Date received
2020-07-27
Decision date
2020-11-25
Days to decision
121 days
Clearance type
Traditional
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
EnSite™ X EP System (K262006)Abbott Medical2026-07-15
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

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Durata Leads; Optisure Leads (P950022/S151)ABBOTT MEDICAL2025-12-09