FDA 510(k)

RHYTHMIA HDx Mapping System

K-Number: K241227 · 2024-08-29

Decision Date2024-08-29

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 2024-08-29 under approval 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. It is manufactured by Boston Scientific Corporation. The 510(k) number is K241227.

When was RHYTHMIA HDx Mapping System approved by the FDA?

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

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.