Atlas FDA

RHYTHMIA HDx™ Mapping System

FDA 510(k) clearance K241227 · decided 2024-08-29

Clearance details

K-number
K241227
Device name
RHYTHMIA HDx™ Mapping System
Applicant
Boston Scientific Corporation
Decision
Substantially Equivalent
Date received
2024-05-02
Decision date
2024-08-29
Days to decision
119 days
Clearance type
Traditional
Product code
DQK
Device class
2
Regulation number
870.1425
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
St Paul, MN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

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CorVista System® with PCWP Add-On (K253576)Analytics For Life, Inc.2026-07-26
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ZEUS Platform (FG0501US) (K252859)iRhythm Technologies, Inc.2026-05-29
EnSite™ X EP System (K260212)ABBOTT MEDICAL2026-04-20
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Synchrony (K253473)Stereotaxis, Inc.2026-04-01
HemoSphere Nano Monitor (HSNANO1) (K253186)Edwards Lifesciences, LLC2026-02-24

Recalls involving this device

No recalls on record reference this clearance.

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