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FDA 510(k)

Polaris X Unidirectional Steerable Diagnostic Catheter

K-Number: K211494 · 2021-09-14

ApplicantBoston Scientific Corporation
Decision Date2021-09-14
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Polaris X Unidirectional Steerable Diagnostic Catheter is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2021-09-14 under approval number K211494. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Polaris X Unidirectional Steerable Diagnostic Catheter?

Polaris X Unidirectional Steerable Diagnostic Catheter is a medical device that received FDA 510(k) clearance on 2021-09-14. It is manufactured by Boston Scientific Corporation. The 510(k) number is K211494.

When was Polaris X Unidirectional Steerable Diagnostic Catheter approved by the FDA?

Polaris X Unidirectional Steerable Diagnostic Catheter received FDA 510(k) clearance on 2021-09-14, under approval number K211494.

What company makes Polaris X Unidirectional Steerable Diagnostic Catheter?

Polaris X Unidirectional Steerable Diagnostic Catheter is manufactured by Boston Scientific Corporation.

What is the FDA product code for Polaris X Unidirectional Steerable Diagnostic Catheter?

The FDA product code for Polaris X Unidirectional Steerable Diagnostic Catheter is DRF.

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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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