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FDA 510(k)

Vertex(TM) Catheter

K-Number: K252027 · 2025-09-12

ApplicantJupiter Endovascular
Decision Date2025-09-12
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Vertex(TM) Catheter is a medical device manufactured by Jupiter Endovascular. It received FDA 510(k) clearance on 2025-09-12 under approval number K252027. 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 Vertex(TM) Catheter?

Vertex(TM) Catheter is a medical device that received FDA 510(k) clearance on 2025-09-12. It is manufactured by Jupiter Endovascular. The 510(k) number is K252027.

When was Vertex(TM) Catheter approved by the FDA?

Vertex(TM) Catheter received FDA 510(k) clearance on 2025-09-12, under approval number K252027.

What company makes Vertex(TM) Catheter?

Vertex(TM) Catheter is manufactured by Jupiter Endovascular.

What is the FDA product code for Vertex(TM) Catheter?

The FDA product code for Vertex(TM) Catheter 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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