ClearGuard HD Antimicrobial Barrier Cap— 510(k) K180111

Name: FDA 510(k) clearance K180111
Creator: U.S. Food and Drug Administration
Published: 2018-05-25

Substantially Equivalent

Pursuit Vascular, Inc.

FDA 510(k) clearance K180111 for ClearGuard HD Antimicrobial Barrier Cap, Substantially Equivalent on 2018-05-25. Applicant: Pursuit Vascular, Inc.. Device class: 2.

Clearance details

Applicant: Pursuit Vascular, Inc.
Product code: Code PEH
Device class: Class 2
Regulation: 21 CFR 876.5540
Advisory panel: Gastroenterology, Urology
Date received: 2018-01-16
Decision date: 2018-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Grove, MN, US

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