510(k) K872838

Device
NORFOLK NORPORT (TM) -SP (SKIN PARALLEL)
Applicant
NORFOLK MEDICAL PRODUCTS, INC.
510(k) number
K872838
Product code
LJT  
Decision
Substantially Equivalent (SESE)
Decision date
1987-08-25
Date received
1987-07-20
Regulation
880.5965
Classification name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MICHAEL J DALTON
Address
7307 N. Ridgeway Skokie IL US 60076 60076

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LJT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252478Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable PortBard Access Systems, Inc.2025-09-05
K251253PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable PortBard Access Systems, Inc.2025-06-18
K242328PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable PortsBard Access Systems, Inc.2024-10-31
K232737PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG Enabled Implantable Port; PowerPort™ isp M.R.I.™ ECG Enabled Implantable Port; PowerPort™ Slim ECG Enabled Implantable PortBard Peripheral Vascular, Inc.2023-12-08
K190559SmartPort+ Implantable Ports, SmartPort Plastic Implantable PortsAngioDynamics, Inc.2020-05-22
K181446Bard Power-Injectable Implantable Ports (PowerPorts®)C.R. Bard, Inc.2019-07-08
K151239NMI DUAL PORT IINavilyst Medical, Inc.2016-06-06
K153359BardPort®, SlimPort®, and X-Port® Implanted PortsC.R. Bard, Inc.2016-05-20
K153238Dignity Dual PortMedcomp ( Medical Components)2016-03-15
K153228NMI Port, NMI Port IINavilyst Medical, Inc.2015-12-04
K150514Power-Injectable Implantable Ports with ChronoFlex Polyurethane CathetersC.R. Bard, Inc.2015-11-20
K150733Vital-Port Vascular Access System Power Injectable PortCook Incorporated2015-05-21
K141146INVISIPORTStealth Therapeutics, Incorporated2015-05-01
K140169VITAL-PORT(R) CT VASCULAR ACCESS SYSTEMCook Incorporated2014-05-21
K133335POWERPORT IMPLANTABLE PORTC.R. Bard, Inc.2014-02-14

Legacy Summary#

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FDA Review#

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