FDA 510(k)

Bard Vertus Foley Catheter

K-Number: K180781 · 2018-09-19

Decision Date2018-09-19

Product CodeEZL

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Bard Vertus Foley Catheter is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2018-09-19 under 510(k) number K180781. 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 Bard Vertus Foley Catheter?

Bard Vertus Foley Catheter is a medical device that received FDA 510(k) clearance on 2018-09-19. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K180781.

When did Bard Vertus Foley Catheter receive FDA 510(k) clearance?

Bard Vertus Foley Catheter received FDA 510(k) clearance on 2018-09-19, under 510(k) number K180781.

Who is the listed applicant for Bard Vertus Foley Catheter?

The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bard Vertus Foley Catheter?

The FDA product code for Bard Vertus Foley Catheter is EZL.

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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.