FDA 510(k)

OptiMap System

K-Number: K251344 · 2025-05-28

Decision Date2025-05-28

Product CodeDQK

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

OptiMap System is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2025-05-28 under approval number K251344. 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 OptiMap System?

OptiMap System is a medical device that received FDA 510(k) clearance on 2025-05-28. It is manufactured by Boston Scientific Corporation. The 510(k) number is K251344.

When was OptiMap System approved by the FDA?

OptiMap System received FDA 510(k) clearance on 2025-05-28, under approval number K251344.

What company makes OptiMap System?

OptiMap System is manufactured by Boston Scientific Corporation.

What is the FDA product code for OptiMap System?

The FDA product code for OptiMap System is DQK.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.