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FDA 510(k)

Cure Catheter Closed System; Cure Dextra Closed System

K-Number: K230400 · 2023-11-08

ApplicantConvatec, Inc.
Decision Date2023-11-08
Product CodeEZD
Advisory CommitteeGU
DecisionUnknown

Device Summary

Cure Catheter Closed System; Cure Dextra Closed System is a medical device manufactured by Convatec, Inc.. It received FDA 510(k) clearance on 2023-11-08 under approval number K230400. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Cure Catheter Closed System; Cure Dextra Closed System?

Cure Catheter Closed System; Cure Dextra Closed System is a medical device that received FDA 510(k) clearance on 2023-11-08. It is manufactured by Convatec, Inc.. The 510(k) number is K230400.

When was Cure Catheter Closed System; Cure Dextra Closed System approved by the FDA?

Cure Catheter Closed System; Cure Dextra Closed System received FDA 510(k) clearance on 2023-11-08, under approval number K230400.

What company makes Cure Catheter Closed System; Cure Dextra Closed System?

Cure Catheter Closed System; Cure Dextra Closed System is manufactured by Convatec, Inc..

What is the FDA product code for Cure Catheter Closed System; Cure Dextra Closed System?

The FDA product code for Cure Catheter Closed System; Cure Dextra Closed System is EZD.

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Other Devices by Convatec, Inc.

K221593Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus

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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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