PowerFlow Apheresis I.V. Port— 510(k) K163001

Clearance details

Applicant

C.R. Bard, Inc.

Product code

Code PTD

Device class

Class 2

Regulation

21 CFR 880.5965

Advisory panel

General Hospital

Date received

2016-10-28

Decision date

2017-04-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Salt Lake Ciy,, UT, US

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• Z-1579-2020 — PowerFlow Implatable Apheresis IV Port with attachable 9.6 F ChronoFl x Open-Ended Single-Lumen Venous Catheter, Ref A710962, UDI:(01)00801741129438 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.Class II·Terminated·Bard Peripheral Vascular Inc·20191001

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K163001.