510(k) K251253

Device
PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable Port
Applicant
Bard Access Systems, Inc.
510(k) number
K251253
Product code
LJT
Decision
Substantially Equivalent (SESE)
Decision date
2025-06-18
Date received
2025-04-23
Regulation
880.5965
Classification name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Aaron Roessler
Address
605 N. 5600 W. Salt Lake Ciy, UT US 84116 84116

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code LJT

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
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
K132177MEDCOMP GEN III POWER INJECTABLE PORTMedcomp ( Medical Components)2013-12-12