Cleared Traditional

PowerFlow Apheresis I.V. Port

K163001 · C.R. Bard, Inc. · General Hospital

Apr 2017

Decision

171d

Days

Class 2

Risk

About This 510(k) Submission

K163001 is an FDA 510(k) clearance for the PowerFlow Apheresis I.V. Port, a Subcutaneous Implanted Apheresis Port (Class II — Special Controls, product code PTD), submitted by C.R. Bard, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on April 17, 2017, 171 days after receiving the submission on October 28, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5965.

Submission Details

510(k) Number	K163001 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 28, 2016
Decision Date	April 17, 2017
Days to Decision	171 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	PTD — Subcutaneous Implanted Apheresis Port
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5965
Definition	A Subcutaneous Implanted Apheresis Port Is A Prescription Device Intended For Patient Therapies Requiring Repeated Access To The Vascular System And Long-term Therapeutic Apheresis