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FDA 510(k)

iLab Polaris Multi-Modality Guidance System

K-Number: K191008 · 2019-07-02

ApplicantBoston Scientific Corporation
Decision Date2019-07-02
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

iLab Polaris Multi-Modality Guidance System is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2019-07-02 under 510(k) number K191008. 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 2019-07-02. The listed applicant is Boston Scientific Corporation. The 510(k) number is K191008.

When did iLab Polaris Multi-Modality Guidance System receive FDA 510(k) clearance?

iLab Polaris Multi-Modality Guidance System received FDA 510(k) clearance on 2019-07-02, under 510(k) number K191008.

Who is the listed applicant for iLab Polaris Multi-Modality Guidance System?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

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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Related Devices (Code: 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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