FDA 510(k)

RHYTHMIA HDx Mapping System (with software Version 2.0)

K-Number: K173837 · 2018-07-25

Decision Date2018-07-25

Product CodeDQK

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

RHYTHMIA HDx Mapping System (with software Version 2.0) 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 2018-07-25 under 510(k) number K173837. 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 (with software Version 2.0)?

RHYTHMIA HDx Mapping System (with software Version 2.0) is a medical device that received FDA 510(k) clearance on 2018-07-25. The listed applicant is Boston Scientific Corporation. The 510(k) number is K173837.

When did RHYTHMIA HDx Mapping System (with software Version 2.0) receive FDA 510(k) clearance?

RHYTHMIA HDx Mapping System (with software Version 2.0) received FDA 510(k) clearance on 2018-07-25, under 510(k) number K173837.

Who is the listed applicant for RHYTHMIA HDx Mapping System (with software Version 2.0)?

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 (with software Version 2.0)?

The FDA product code for RHYTHMIA HDx Mapping System (with software Version 2.0) 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)RECRUITING NCT06808217A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial FibrillationACTIVE_NOT_RECRUITING NCT01385176Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)ACTIVE_NOT_RECRUITING NCT01550575Patient Retrospective Outcomes (PRO)RECRUITING NCT01719055RELIEF - A Global Prospective Observational Post-Market Study to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for PainRECRUITING NCT02071134Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS RegistryRECRUITING

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Related Devices (Code: DQK)

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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.