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FDA 510(k)

RHYTHMIA HDx Mapping System

K-Number: K162793 · 2017-03-10

ApplicantBoston Scientific Corporation
Decision Date2017-03-10
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RHYTHMIA HDx Mapping System is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2017-03-10 under approval number K162793. 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 2017-03-10. It is manufactured by Boston Scientific Corporation. The 510(k) number is K162793.

When was RHYTHMIA HDx Mapping System approved by the FDA?

RHYTHMIA HDx Mapping System received FDA 510(k) clearance on 2017-03-10, under approval number K162793.

What company makes RHYTHMIA HDx Mapping System?

RHYTHMIA HDx Mapping System is manufactured by Boston Scientific Corporation.

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

The FDA product code for RHYTHMIA HDx 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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