Home / 510(k) Clearances / K182644

510(k) K182644

EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 by Abbott — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2018
Date Received
September 24, 2018
Clearance Type
Special
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

  • K251221 — Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) (September 17, 2025)
  • K233655 — Lingo Glucose System (May 29, 2024)
  • K222297 — CentriMag Pre-connected Pack (December 1, 2022)
  • K221213 — EnSite X EP System (August 18, 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)

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)