FDA 510(k)

Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable

K-Number: K230503 · 2023-04-25

Decision Date2023-04-25

Product CodeDRF

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific. It received FDA 510(k) clearance on 2023-04-25 under 510(k) number K230503. 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™ Catheter Cable, Blazer™ Dx-20 Catheter Cable?

Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable is a medical device that received FDA 510(k) clearance on 2023-04-25. The listed applicant is Boston Scientific. The 510(k) number is K230503.

When did Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable receive FDA 510(k) clearance?

Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable received FDA 510(k) clearance on 2023-04-25, under 510(k) number K230503.

Who is the listed applicant for Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable?

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

What is the FDA product code for Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable?

The FDA product code for Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable is DRF.

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Related Devices (Code: 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.