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510(k) K260212

EnSite™ X EP System by ABBOTT MEDICAL — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2026
Date Received
January 23, 2026
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

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Other clearances for product code DQK

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  • K252859 — ZEUS Platform (FG0501US) (May 29, 2026)
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  • K253473 — Synchrony (April 1, 2026)
  • 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)