Cleared Traditional

K180111 - ClearGuard HD Antimicrobial Barrier Cap

K180111 is an FDA 510(k) clearance for ClearGuard HD Antimicrobial Barrier Cap, manufactured by Pursuit Vascular, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code PEH cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K180111 · Pursuit Vascular, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2018
Decision
129d
Days
Class 2
Risk

K180111 is an FDA 510(k) clearance for the ClearGuard HD Antimicrobial Barrier Cap. Classified as Hemodialysis Catheter Luer End Cap (product code PEH), Class II - Special Controls.

Submitted by Pursuit Vascular, Inc. (Maple Grove, US). The FDA issued a Cleared decision on May 25, 2018 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Pursuit Vascular, Inc. devices

FDA 510(k) Submission Details - K180111

510(k) Number K180111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2018
Decision Date May 25, 2018
Days to Decision 129 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 130d · This submission: 129d
Pathway characteristics
Predicate-based equivalence.

PEH Device Classification - Class 2, Special Controls

Product Code PEH Hemodialysis Catheter Luer End Cap
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
Definition For Use In Hemodialysis Catheters To Reduce Hub Infection.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Gastroenterology & Urology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02593149 Completed Interventional Industry-sponsored

Product Evaluation for the Effectiveness of the ClearGuard® HD End Cap

1902
Patients (actual)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied End Stage Renal Disease (ESRD)
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Steven M Brunelli, MD, MSCE
Sponsor Pursuit Vascular, Inc. (industry)
Started 2015-11-01 → Primary completion 2016-11-01
Primary outcome
Positive Blood Cultures (PBC's) Per 1,000 Central Venous Catheter (CVC)-Days
View full study on ClinicalTrials.gov