FDA 510(k)

Blazer Dx-20 Bidirectional Steerable Diagnostic Catheter

K-Number: K211375 · 2021-09-10

Decision Date2021-09-10

Product CodeDRF

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Blazer Dx-20 Bidirectional Steerable Diagnostic Catheter is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2021-09-10 under approval number K211375. 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 Blazer Dx-20 Bidirectional Steerable Diagnostic Catheter?

Blazer Dx-20 Bidirectional Steerable Diagnostic Catheter is a medical device that received FDA 510(k) clearance on 2021-09-10. It is manufactured by Boston Scientific Corporation. The 510(k) number is K211375.

When was Blazer Dx-20 Bidirectional Steerable Diagnostic Catheter approved by the FDA?

Blazer Dx-20 Bidirectional Steerable Diagnostic Catheter received FDA 510(k) clearance on 2021-09-10, under approval number K211375.

What company makes Blazer Dx-20 Bidirectional Steerable Diagnostic Catheter?

Blazer Dx-20 Bidirectional Steerable Diagnostic Catheter is manufactured by Boston Scientific Corporation.

What is the FDA product code for Blazer Dx-20 Bidirectional Steerable Diagnostic Catheter?

The FDA product code for Blazer Dx-20 Bidirectional Steerable Diagnostic Catheter is DRF.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.