Cleared Special

PowerPort? isp Implantable Port; PowerPort? Slim Implantable Port; PowerPort? M.R.I. ? Implantable Port; PowerPort? M.R.I.? isp Implantable Port

K251253 · Bard Access Systems, Inc. · General Hospital
Jun 2025
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K251253 is an FDA 510(k) clearance for the PowerPort? isp Implantable Port; PowerPort? Slim Implantable Port; PowerPort? M.R.I. ? Implantable Port; PowerPort? M.R.I.? isp Implantable Port, 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 June 18, 2025, 56 days after receiving the submission on April 23, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5965.

Submission Details

510(k) Number K251253 FDA.gov
FDA Decision Cleared SESE
Date Received April 23, 2025
Decision Date June 18, 2025
Days to Decision 56 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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