PowerFlow Apheresis I.V. Port

FDA 510(k) K163001 · C.R. Bard, Inc.

Substantially Equivalent

510(k) numberK163001

Submission

Device name
PowerFlow Apheresis I.V. Port
Applicant
C.R. Bard, Inc.
Salt Lake Ciy,, UT, US
Received
October 28, 2016
Decision date
April 17, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PTD – Subcutaneous Implanted Apheresis Port
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5965
Specialty
General Hospital
Implant
Yes

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

Other 510(k)s with product code PTD

510(k)DeviceApplicantDecision
K192291TidalPort-AP Implantable Apheresis Vascular Access PortPTD · Traditional Norfolk Medical Products, Inc.08/20/2020SE
K191143PowerFlow Implantable Apheresis IV PortPTD · Traditional C.R. Bard, Inc.08/02/2019SE

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Questions and answers

When was PowerFlow Apheresis I.V. Port cleared by the FDA?

PowerFlow Apheresis I.V. Port (K163001) received a 510(k) decision of Substantially Equivalent on April 17, 2017, 171 days after the submission was received.

What is the product code of K163001?

The FDA product code is PTD – Subcutaneous Implanted Apheresis Port, a Class II (moderate risk) device regulated under 21 CFR 880.5965.