Home / 510(k) Clearances / K160187

510(k) K160187

Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 by St Jude Medical — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2016
Date Received
January 27, 2016
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 St Jude Medical

  • K181382 — GuardianTM Burr Hole Cover System (July 20, 2018)
  • K172396 — EnSite Velocity Cardiac Mapping System v5.2 (April 23, 2018)
  • K173232 — myMerlin(TM) Mobile Application Model APP1001 (November 2, 2017)
  • K162643 — MediGuide Technology System (December 13, 2016)
  • K160210 — EnSite Precision Cardiac Mapping System v2.0 (December 13, 2016)
  • K160218 — AutoMark Module (December 13, 2016)
  • K160335 — Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL (December 13, 2016)
  • K161873 — Pacel Flow Directed Pacing Catheter (November 22, 2016)
  • K160186 — EnSite Velocity Surface Electrode Kit (October 7, 2016)
  • K152342 — Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover (June 9, 2016)

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)