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510(k) K241227

RHYTHMIA HDx™ Mapping System by Boston Scientific Corporation — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2024
Date Received
May 2, 2024
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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  • K253733 — STAR Apollo™ Mapping System (December 19, 2025)
  • K252533 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) (December 18, 2025)
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