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FDA 510(k)

BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter

K-Number: K232651 · 2023-09-29

ApplicantBoston Scientific Corporation
Decision Date2023-09-29
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 2023-09-29 under approval number K232651. 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 2023-09-29. It is manufactured by Boston Scientific Corporation. The 510(k) number is K232651.

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 2023-09-29, under approval number K232651.

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

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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