Cleared Special

PowerPort? ClearVUE? Slim ECG Enabled Implantable Port; PowerPort? ClearVUE? isp ECG Enabled Implantable Port; PowerPort? isp M.R.I.? ECG Enabled Implantable Port; PowerPort? Slim ECG Enabled Implantable Port

K232737 · Bard Peripheral Vascular, Inc. · General Hospital
Dec 2023
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K232737 is an FDA 510(k) clearance for the PowerPort? ClearVUE? Slim ECG Enabled Implantable Port; PowerPort? ClearVUE? isp ECG Enabled Implantable Port; PowerPort? isp M.R.I.? ECG Enabled Implantable Port; PowerPort? Slim ECG Enabled Implantable Port, a Port & Catheter, Implanted, Subcutaneous, Intravascular (Class II — Special Controls, product code LJT), submitted by Bard Peripheral Vascular, Inc. (Tempe, US). The FDA issued a Cleared decision on December 8, 2023, 92 days after receiving the submission on September 7, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5965.

Submission Details

510(k) Number K232737 FDA.gov
FDA Decision Cleared SESE
Date Received September 07, 2023
Decision Date December 08, 2023
Days to Decision 92 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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