Cleared Traditional

PowerFlow Implantable Apheresis IV Port

K191143 · C.R. Bard, Inc. · General Hospital

Aug 2019

Decision

94d

Days

Class 2

Risk

About This 510(k) Submission

K191143 is an FDA 510(k) clearance for the PowerFlow Implantable Apheresis IV 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 August 2, 2019, 94 days after receiving the submission on April 30, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5965.

Submission Details

510(k) Number	K191143 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 30, 2019
Decision Date	August 02, 2019
Days to Decision	94 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