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FDA 510(k)

RHYTHMIA HDx™ Mapping System

K-Number: K241227 · 2024-08-29

ApplicantBoston Scientific Corporation
Decision Date2024-08-29
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RHYTHMIA HDx™ Mapping System is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2024-08-29 under 510(k) number K241227. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RHYTHMIA HDx™ Mapping System?

RHYTHMIA HDx™ Mapping System is a medical device that received FDA 510(k) clearance on 2024-08-29. The listed applicant is Boston Scientific Corporation. The 510(k) number is K241227.

When did RHYTHMIA HDx™ Mapping System receive FDA 510(k) clearance?

RHYTHMIA HDx™ Mapping System received FDA 510(k) clearance on 2024-08-29, under 510(k) number K241227.

Who is the listed applicant for RHYTHMIA HDx™ Mapping System?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RHYTHMIA HDx™ Mapping System?

The FDA product code for RHYTHMIA HDx™ Mapping System is DQK.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT03053141RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY)RECRUITINGNCT01385176Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)ACTIVE_NOT_RECRUITINGNCT01550575Patient Retrospective Outcomes (PRO)RECRUITINGNCT01719055RELIEF - A Global Prospective Observational Post-Market Study to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for PainRECRUITINGNCT02071134Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS RegistryRECRUITINGNCT02686125Vercise™ DBS Dystonia Prospective StudyRECRUITING

Other records listing Boston Scientific Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: DQK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLCK253463ILR ECG Analyzer (IM007)Implicity, Inc.K261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc.K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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