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FDA 510(k)

Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter

K-Number: K181979 · 2019-05-24

ApplicantTeleflexmedical, Inc.
Decision Date2019-05-24
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter is a medical device manufactured by Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2019-05-24 under approval number K181979. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter?

Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter is a medical device that received FDA 510(k) clearance on 2019-05-24. It is manufactured by Teleflexmedical, Inc.. The 510(k) number is K181979.

When was Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter approved by the FDA?

Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter received FDA 510(k) clearance on 2019-05-24, under approval number K181979.

What company makes Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter?

Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter is manufactured by Teleflexmedical, Inc..

What is the FDA product code for Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter?

The FDA product code for Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter is KOD.

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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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