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FDA 510(k)

RHYTHMIA HDx Mapping System (with software Version 2.0)

K-Number: K173837 · 2018-07-25

ApplicantBoston Scientific Corporation
Decision Date2018-07-25
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RHYTHMIA HDx Mapping System (with software Version 2.0) is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2018-07-25 under approval 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. It is manufactured by Boston Scientific Corporation. The 510(k) number is K173837.

When was RHYTHMIA HDx Mapping System (with software Version 2.0) approved by the FDA?

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

What company makes RHYTHMIA HDx Mapping System (with software Version 2.0)?

RHYTHMIA HDx Mapping System (with software Version 2.0) is manufactured by Boston Scientific Corporation.

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.

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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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