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FDA 510(k)

iLab Polaris Multi-Modality Guidance System

K-Number: K201178 · 2020-05-29

ApplicantBoston Scientific
Decision Date2020-05-29
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

iLab Polaris Multi-Modality Guidance System is a medical device manufactured by Boston Scientific. It received FDA 510(k) clearance on 2020-05-29 under approval number K201178. 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 iLab Polaris Multi-Modality Guidance System?

iLab Polaris Multi-Modality Guidance System is a medical device that received FDA 510(k) clearance on 2020-05-29. It is manufactured by Boston Scientific. The 510(k) number is K201178.

When was iLab Polaris Multi-Modality Guidance System approved by the FDA?

iLab Polaris Multi-Modality Guidance System received FDA 510(k) clearance on 2020-05-29, under approval number K201178.

What company makes iLab Polaris Multi-Modality Guidance System?

iLab Polaris Multi-Modality Guidance System is manufactured by Boston Scientific.

What is the FDA product code for iLab Polaris Multi-Modality Guidance System?

The FDA product code for iLab Polaris Multi-Modality Guidance 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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