Cleared Traditional

Bard Power-Injectable Implantable Ports (PowerPorts?)

K181446 · C.R. Bard, Inc. · General Hospital
Jul 2019
Decision
402d
Days
Class 2
Risk

About This 510(k) Submission

K181446 is an FDA 510(k) clearance for the Bard Power-Injectable Implantable Ports (PowerPorts?), a Port & Catheter, Implanted, Subcutaneous, Intravascular (Class II — Special Controls, product code LJT), submitted by C.R. Bard, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on July 8, 2019, 402 days after receiving the submission on June 1, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5965.

Submission Details

510(k) Number K181446 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 2018
Decision Date July 08, 2019
Days to Decision 402 days
Submission Type Traditional
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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