FDA 510(k)

Arise UHP Dilatation Catheter

K-Number: K230191 · 2023-03-22

Decision Date2023-03-22

Product CodeLIT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Arise UHP Dilatation Catheter is a medical device manufactured by Creagh Medical, Ltd.. It received FDA 510(k) clearance on 2023-03-22 under approval number K230191. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arise UHP Dilatation Catheter?

Arise UHP Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2023-03-22. It is manufactured by Creagh Medical, Ltd.. The 510(k) number is K230191.

When was Arise UHP Dilatation Catheter approved by the FDA?

Arise UHP Dilatation Catheter received FDA 510(k) clearance on 2023-03-22, under approval number K230191.

What company makes Arise UHP Dilatation Catheter?

Arise UHP Dilatation Catheter is manufactured by Creagh Medical, Ltd..

What is the FDA product code for Arise UHP Dilatation Catheter?

The FDA product code for Arise UHP Dilatation Catheter is LIT.

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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.