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510(k) K221213

EnSite X EP System by Abbott — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2022
Date Received
April 27, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Programmable
Device Class
Class II
Regulation Number
870.1425
Review Panel
CV
Submission Type

Other clearances by Abbott

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  • K233655 — Lingo Glucose System (May 29, 2024)
  • K222297 — CentriMag Pre-connected Pack (December 1, 2022)
  • K212061 — EnSite X EP System (October 22, 2021)
  • K210392 — WorkMate Claris System (March 11, 2021)
  • K192593 — Confirm Rx Insertable Cardiac Monitor (October 18, 2019)
  • K190167 — MitraClip G4 Steerable Guide Catheter (May 29, 2019)
  • K182981 — Confirm Rx Insertable Cardiac Monitor (March 29, 2019)
  • K183128 — EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping Sy (December 12, 2018)
  • K182644 — EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping Sy (October 19, 2018)

Other clearances for product code DQK

  • K253186 — HemoSphere Nano Monitor (HSNANO1) (February 24, 2026)
  • K252972 — CARTO™ 3 EP Navigation System V8.4 (February 20, 2026)
  • K254089 — IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751 (February 17, 2026)
  • K251591 — Holter ECG and ABP system (HolterABP) (February 9, 2026)
  • K251218 — SafeBeat Rx App (February 6, 2026)
  • K252164 — NorthStar™ Mapping System (January 28, 2026)
  • K254085 — CARTO™ 3 EP Navigation System V9.0 with PIU Plus (January 18, 2026)
  • K253733 — STAR Apollo™ Mapping System (December 19, 2025)
  • K252533 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) (December 18, 2025)
  • K253141 — DeepRhythmAI (December 11, 2025)