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FDA 510(k)

Dib UltraNav Transseptal Catheter System

K-Number: K213492 · 2022-03-24

ApplicantDib Ultranav Medical, LLC
Decision Date2022-03-24
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Dib UltraNav Transseptal Catheter System is a medical device manufactured by Dib Ultranav Medical, LLC. It received FDA 510(k) clearance on 2022-03-24 under approval number K213492. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dib UltraNav Transseptal Catheter System?

Dib UltraNav Transseptal Catheter System is a medical device that received FDA 510(k) clearance on 2022-03-24. It is manufactured by Dib Ultranav Medical, LLC. The 510(k) number is K213492.

When was Dib UltraNav Transseptal Catheter System approved by the FDA?

Dib UltraNav Transseptal Catheter System received FDA 510(k) clearance on 2022-03-24, under approval number K213492.

What company makes Dib UltraNav Transseptal Catheter System?

Dib UltraNav Transseptal Catheter System is manufactured by Dib Ultranav Medical, LLC.

What is the FDA product code for Dib UltraNav Transseptal Catheter System?

The FDA product code for Dib UltraNav Transseptal Catheter System is DYB.

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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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