ClearGuard HD Antimicrobial Barrier Cap
K-Number: K180111 · 2018-05-25
ApplicantPursuit Vascular, Inc.
Decision Date2018-05-25
Product CodePEH
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
ClearGuard HD Antimicrobial Barrier Cap is a medical device manufactured by Pursuit Vascular, Inc.. It received FDA 510(k) clearance on 2018-05-25 under approval 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. It is manufactured by Pursuit Vascular, Inc.. The 510(k) number is K180111.
When was ClearGuard HD Antimicrobial Barrier Cap approved by the FDA?
ClearGuard HD Antimicrobial Barrier Cap received FDA 510(k) clearance on 2018-05-25, under approval number K180111.
What company makes ClearGuard HD Antimicrobial Barrier Cap?
ClearGuard HD Antimicrobial Barrier Cap is manufactured by Pursuit Vascular, Inc..
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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.