FDA 510(k)

ClearGuard HD Antimicrobial Barrier Cap

K-Number: K180111 · 2018-05-25

Decision Date2018-05-25

Product CodePEH

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

ClearGuard HD Antimicrobial Barrier Cap is the device name listed in this FDA 510(k) record. The listed applicant is Pursuit Vascular, Inc.. It received FDA 510(k) clearance on 2018-05-25 under 510(k) number K180111. The device is classified under product code PEH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ClearGuard HD Antimicrobial Barrier Cap?

ClearGuard HD Antimicrobial Barrier Cap is a medical device that received FDA 510(k) clearance on 2018-05-25. The listed applicant is Pursuit Vascular, Inc.. The 510(k) number is K180111.

When did ClearGuard HD Antimicrobial Barrier Cap receive FDA 510(k) clearance?

ClearGuard HD Antimicrobial Barrier Cap received FDA 510(k) clearance on 2018-05-25, under 510(k) number K180111.

Who is the listed applicant for ClearGuard HD Antimicrobial Barrier Cap?

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

What is the FDA product code for ClearGuard HD Antimicrobial Barrier Cap?

The FDA product code for ClearGuard HD Antimicrobial Barrier Cap is PEH.

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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.