Cleared Special

PowerPort? ClearVUE? Slim Implantable Ports and PowerPort? ClearVUE? Slim Implantable Ports

K242328 · Bard Access Systems, Inc. · General Hospital
Oct 2024
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K242328 is an FDA 510(k) clearance for the PowerPort? ClearVUE? Slim Implantable Ports and PowerPort? ClearVUE? Slim Implantable Ports, a Port & Catheter, Implanted, Subcutaneous, Intravascular (Class II — Special Controls, product code LJT), submitted by Bard Access Systems, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on October 31, 2024, 86 days after receiving the submission on August 6, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5965.

Submission Details

510(k) Number K242328 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 2024
Decision Date October 31, 2024
Days to Decision 86 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LJT — Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5965

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