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FDA 510(k)

Rusch Simplastic Foley Catheters

K-Number: K162989 · 2017-02-24

Decision Date2017-02-24
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Rusch Simplastic Foley Catheters is a medical device manufactured by Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2017-02-24 under approval number K162989. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rusch Simplastic Foley Catheters?

Rusch Simplastic Foley Catheters is a medical device that received FDA 510(k) clearance on 2017-02-24. It is manufactured by Teleflexmedical, Inc.. The 510(k) number is K162989.

When was Rusch Simplastic Foley Catheters approved by the FDA?

Rusch Simplastic Foley Catheters received FDA 510(k) clearance on 2017-02-24, under approval number K162989.

What company makes Rusch Simplastic Foley Catheters?

Rusch Simplastic Foley Catheters is manufactured by Teleflexmedical, Inc..

What is the FDA product code for Rusch Simplastic Foley Catheters?

The FDA product code for Rusch Simplastic Foley Catheters is EZL.

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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.