Product code LJT

Current FDA Classification

Device name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Medical specialty
General Hospital
Device class
2
Regulation number
880.5965
Review panel
HO
Implant
Y
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible

Related 510(k) Records

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
K132177MEDCOMP GEN III POWER INJECTABLE PORTMedcomp ( Medical Components)2013-12-12
K122834POLYSITE IMPLANTABLE INFUSION PORTSPerouse Medical2013-12-11
K131694NMI PORT II CATHETERNavilyst Medical, Inc.2013-08-08
K1309235F DIGNITY CT TITANIUM PORTMedical Components, Inc.2013-07-31
K122402LPP (LOW PROFILE PORT)Pfm Medical, Inc.2013-07-16
K122767NMI PORTNavilyst Medical, Inc.2013-04-30
K130576CELSITE IMPLANTABLE ACCESS PORT SYSTEMSB. Braun Interventional Systems, Inc.2013-04-02
K122899POWERPORT CLEARVUE SLIM IMPLANTABLE PORTC.R. Bard, Inc.2012-11-15
K120281DIGNITY POWER INJECTABLE TITANIUM PORTMedical Components, Inc.2012-09-17
K110424DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROFILE PORT- ATTACHABLE; DIGNITY LOW PROFILMedcomp ( Medical Components)2011-11-30
K112713NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTSNorfolk Medical Products, Inc.2011-10-27
K110407INVISIPORTStealth Therapeutics, Incorporated2011-10-13
K111101NORPORT CT-PC, LUCENT NON-CORING NEEDEL INFUSION SETNorfolk Medical2011-08-25
K102385NORFOLK MEDICAL NORPORT FAMILY OF PORTSNorfolk Medical Products, Inc.2011-01-14
K101017ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMSAngioDynamics, Inc.2010-06-17

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