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 a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2019-07-02 under approval 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. It is manufactured by Boston Scientific Corporation. The 510(k) number is K191008.
When was iLab Polaris Multi-Modality Guidance System approved by the FDA?
iLab Polaris Multi-Modality Guidance System received FDA 510(k) clearance on 2019-07-02, under approval number K191008.
What company makes iLab Polaris Multi-Modality Guidance System?
iLab Polaris Multi-Modality Guidance System is manufactured by Boston Scientific Corporation.
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.