ClearGuard HD Antimicrobial Barrier Cap

Hemodialysis Catheter Luer End Cap

Pursuit Vascular, Inc.

The following data is part of a premarket notification filed by Pursuit Vascular, Inc. with the FDA for Clearguard Hd Antimicrobial Barrier Cap.

Pre-market Notification Details

Device IDK180111
510k NumberK180111
Device Name:ClearGuard HD Antimicrobial Barrier Cap
ClassificationHemodialysis Catheter Luer End Cap
Applicant Pursuit Vascular, Inc. 6901 East Fish Lake Road, Suite 166 Maple Grove,  MN  55369
ContactDouglas Killion
CorrespondentLaurie Lynch
Pursuit Vascular, Inc. 6901 East Fish Lake Road, Suite 166 Maple Grove,  MN  55369
Product CodePEH  
CFR Regulation Number876.5540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-01-16
Decision Date2018-05-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10887709123585 K180111 000
10887709123592 K180111 000

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