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FDA 510(k)

Rhythmia HDxTM Mapping System

K-Number: K192438 · 2019-11-27

ApplicantBoston Scientific Corporation
Decision Date2019-11-27
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Rhythmia HDxTM Mapping System is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2019-11-27 under approval number K192438. 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 HDxTM Mapping System?

Rhythmia HDxTM Mapping System is a medical device that received FDA 510(k) clearance on 2019-11-27. It is manufactured by Boston Scientific Corporation. The 510(k) number is K192438.

When was Rhythmia HDxTM Mapping System approved by the FDA?

Rhythmia HDxTM Mapping System received FDA 510(k) clearance on 2019-11-27, under approval number K192438.

What company makes Rhythmia HDxTM Mapping System?

Rhythmia HDxTM Mapping System is manufactured by Boston Scientific Corporation.

What is the FDA product code for Rhythmia HDxTM Mapping System?

The FDA product code for Rhythmia HDxTM Mapping System is 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.

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