TidalPort-AP Implantable Apheresis Vascular Access Port

FDA 510(k) K192291 · Norfolk Medical Products, Inc.

Substantially Equivalent

510(k) numberK192291

Submission

Device name
TidalPort-AP Implantable Apheresis Vascular Access Port
Applicant
Norfolk Medical Products, Inc.
Skokie, IL, US
Received
August 23, 2019
Decision date
August 20, 2020
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
K191143PowerFlow Implantable Apheresis IV PortPTD · Traditional C.R. Bard, Inc.08/02/2019SE
K163001PowerFlow Apheresis I.V. PortPTD · Traditional C.R. Bard, Inc.04/17/2017SE

More from C.R. Bard, Inc.

510(k)DeviceDecision
K112713Norfolk Medical-Sportport-Family of PortsLJT · Special 10/27/2011SE
K102385Norfolk Medical Norport Family of PortsLJT · Traditional 01/14/2011SE
K942784Norfolk Omega Port-Lp Subcutaneously ImplantedLJT · Traditional 05/02/1995SE
K896544MD2 Personal Infusion SystemFRN · Traditional 05/02/1990SE
K872838Norfolk Norport (TM) -Sp (Skin Parallel)LJT · Traditional 08/25/1987SE
K871209Norfolk Medical NorportLJT · Traditional 06/24/1987SE
K871192Subcutaneously Implanted Drug Delivery DepotLJT · Traditional 06/10/1987SE
K870187Norfolk Norport, Subcut. Implanted Drug Del. DepotLJT · Traditional 05/07/1987SE
K870519Subcutaneously Implanted Drug Delivery DepotLJT · Traditional 04/15/1987SE
K870188Norfolk Medical Butterfly Infusion SetFPA · Traditional 02/10/1987SE

Questions and answers

When was TidalPort-AP Implantable Apheresis Vascular Access Port cleared by the FDA?

TidalPort-AP Implantable Apheresis Vascular Access Port (K192291) received a 510(k) decision of Substantially Equivalent on August 20, 2020, 363 days after the submission was received.

What is the product code of K192291?

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