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FDA 510(k)

Polaris X™ Unidirectional Steerable Diagnostic Catheter

K-Number: K233207 · 2023-10-27

ApplicantBoston Scientific Corporation
Decision Date2023-10-27
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 2023-10-27 under approval number K233207. 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 2023-10-27. It is manufactured by Boston Scientific Corporation. The 510(k) number is K233207.

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

Polaris X™ Unidirectional Steerable Diagnostic Catheter received FDA 510(k) clearance on 2023-10-27, under approval number K233207.

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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