ClearanceBrief
Panels › General Hospital › Product code LJT · Class 2

Port & Catheter, Implanted, Subcutaneous, Intravascular

Regulation 880.5965

1510(k)s in 12 months (288 all time)
1recalls in 12 months (141 all time)
131recalls that name a 510(k)
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Top companies in LJT

DateFirm and productCodeLinked 510(k)
Jun 13, 2026ARROW INTERNATIONAL, LLC
Description/REF: PICC ACCESS TRAY/ASK-04001-CG1
Open, Classified
LJTK003006
Sep 5, 2025B.Braun Medical S.A.S.
Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog Number: 5433742 Software Version: N/A Product Description: CELSITE BABYPORT SET PUR 4,5F IV USA Component: N/A
Open, Classified
LJTK130576
K952435
Mar 18, 2025Smiths Medical ASD, Inc.
smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-24
Open, Classified
LJTK994216
Mar 18, 2025Smiths Medical ASD, Inc.
smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introducer, REF 21-4183-24
Open, Classified
LJTK994216
Mar 18, 2025Smiths Medical ASD, Inc.
smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24
Open, Classified
LJTNone listed
Mar 18, 2025Smiths Medical ASD, Inc.
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4173-24
Open, Classified
LJTNone listed
Mar 18, 2025Smiths Medical ASD, Inc.
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4172-24
Open, Classified
LJTNone listed
Mar 18, 2025Smiths Medical ASD, Inc.
smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4171-24
Open, Classified
LJTK994216
Mar 18, 2025Smiths Medical ASD, Inc.
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introducer, REF 21-4165-24
Open, Classified
LJTK994216
Mar 18, 2025Smiths Medical ASD, Inc.
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4155-24
Open, Classified
LJTK994216
Mar 18, 2025Smiths Medical ASD, Inc.
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6Fr Introducer, REF 21-4153-24
Open, Classified
LJTK994216
Mar 18, 2025Smiths Medical ASD, Inc.
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., REF 21-4152-24
Open, Classified
LJTNone listed
Mar 18, 2025Smiths Medical ASD, Inc.
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer, REF 21-4151-24
Open, Classified
LJTNone listed
Mar 18, 2025Smiths Medical ASD, Inc.
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24
Open, Classified
LJTNone listed
Oct 25, 2022Angiodynamics, Inc.
Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray. Indicated for central venous placement (either peripheral or chest placement) when patient therapy requ
Open, Classified
LJTK033473
Mar 25, 2021Bard Peripheral Vascular Inc
PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 5829502, UDI: (01)00801741027406 - Product Usage: The port system can be used for inf
Terminated
LJTK090512
Mar 25, 2021Bard Peripheral Vascular Inc
PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829570, UDI: (01) 00801741027192 - Product Usage: The port system can be used for in
Terminated
LJTK090512
Mar 25, 2021Bard Peripheral Vascular Inc
PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829500, UDI: (01) 00801741027185 - Product Usage: The port system can be used for in
Terminated
LJTK090512
Mar 8, 2021Medical Components, Inc dba MedComp
Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system.
Open, Classified
LJTK132177
Feb 22, 2021Angiodynamics Inc. (Navilyst Medical Inc.)
Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient requiring repeated access of the vascular system, for delivery of medications, nutrition
Terminated
LJTK062414
Jun 11, 2020Smiths Medical ASD Inc.
PORT-A-CATH II POWER P.A.C. Low Profile" system.
Terminated
LJTK072657
Jan 15, 2020Bard Peripheral Vascular Inc
BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Septum and Attachable 6 F Polyurethane Open-Ended Single-Lumen Venous Catheter, Product #5676300 - Product Usage: All materials
Open, Classified
LJTK122899
Oct 1, 2019Bard Peripheral Vascular Inc
PowerFlow Implatable Apheresis IV Port with attachable 9.6 F ChronoFl x Open-Ended Single-Lumen Venous Catheter, Ref A710962, UDI:(01)00801741129438 Product Usage: Bard implantable ports are indicated
Terminated
LJTK163001
Oct 1, 2019Bard Peripheral Vascular Inc
1. X-Port isp M.R.I Implantable Port, with Pre-Attached 9.6 F Open-Ended Single-Lumen Venous Catheter, REF:0607550, UDI:(01)00801741026195 2. X-Port isp M.R.I. Implantable Port, with Attachable 9.6F O
Terminated
LJTK022983
Oct 1, 2019Bard Peripheral Vascular Inc
BardPort M.R.I. Hard Base Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter, Ref: 0604550, UDI: (01)00801741025860 Product Usage: Bard implantable ports are indicated for
Terminated
LJTK873213
Oct 1, 2019Bard Peripheral Vascular Inc
BardPort M.R.I. Implantable Port with Attachale 9.6 F Open-Ended Single-Lumen Venous Catheter, REF: 0602680, UDI:(01)00801741025679 Product Usage: Bard implantable ports are indicated for patient ther
Terminated
LJTK873213
Oct 1, 2019Bard Peripheral Vascular Inc
BardPort Titanium Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter , REF: 0602230, UDI: (01)00801741025563 Product Usage: Bard implantable ports are indicated for patient
Terminated
LJTK050310
Oct 1, 2019Bard Peripheral Vascular Inc
1. Groshong 9.5 Dual-Lumen CV Catheter, Ref: 7726950, UDI: (01)00801741041570; 2. Groshong 9.5 F Dual-Lumen CV Catheter, REF: 7726954, UDI: (01)00801741041587
Terminated
LJTK860256
Oct 1, 2019Bard Peripheral Vascular Inc
1. Vaccess CT Power-Injectable Implantable Port with Suture Plugs, Ref: 7496000, UDI:(01)00801741027482 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated acc
Terminated
LJTK072549
Oct 1, 2019Bard Peripheral Vascular Inc
1. Power Port isp M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter with Suture Plugs, Ref: 1809660, UDI: (01)00801741027154 2. PowerPort isp M.R.I. Implantable Por
Terminated
LJTK073423
Oct 1, 2019Bard Peripheral Vascular Inc
1. PowerPort M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter with Suture Plugs, REF: 1809600, UDI: (01)00801741027130 ; 2. PowerPort M.R.I. Implantable Port with
Terminated
LJTK073423
Oct 1, 2019Bard Peripheral Vascular Inc
1.PowerPort Implantable Port With Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter REF: 1709600, Air Guard, With suture Plugs, (01)00801741026720; 2. PowerPort Implantable Port With Attachab
Terminated
LJTK073423
Sep 18, 2019Angiodynamics Inc. (Navilyst Medical Inc.)
XCELA, 8F SINGLE PLASTIC PORT FILLED, VALVED, UPN H965440400, Cat. No. 44-040 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to h
Terminated
LJTK122767
Sep 18, 2019Angiodynamics Inc. (Navilyst Medical Inc.)
BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022
Terminated
LJTK122767
Sep 18, 2019Angiodynamics Inc. (Navilyst Medical Inc.)
BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED, UPN H965440210, Cat. No. 44-021 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hy
Terminated
LJTK122767
Sep 18, 2019Angiodynamics Inc. (Navilyst Medical Inc.)
BIOFLO 8F SINGLE TITANIUM NON- FILLED; VALVED, UPN H965440250, Cat. No. 44-025 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to
Terminated
LJTK122767
Sep 18, 2019Angiodynamics Inc. (Navilyst Medical Inc.)
BIOFLO 8F SINGLE PLASTIC FILLED; NON-VALVED, UPN H965440140, Cat. No. 44-014 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hy
Terminated
LJTK122767
Jul 8, 2019Smiths Medical ASD Inc.
GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled as the following item descriptions: 1. TRAY, PAC, VEN, TI, PU, 1.9MM, UL, 6FR/INTRO 1/EA; 2. TRAY, PAC, VEN LP, T
Terminated
LJTK072657
Feb 14, 2019Bard Peripheral Vascular Inc
PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter
Open, Classified
LJTK063377
Jul 24, 2018Angiodynamics Inc. (Navilyst Medical Inc.)
BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED PG UPN: H965440210 Catalog Number: 44-021 Box of 1 Port - Product Usage - Long-term access to the
Terminated
LJTK131694
Jun 25, 2018Bard Peripheral Vascular Inc
POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE isp, 8F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 6F CHRONOF
Completed
LJTK063377
K122899
Mar 15, 2018Smiths Medical ASD Inc.
Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as: a. VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); b. VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); c. VEN LP, PU, 1.9MM, UL, 6 FR/IN
Terminated
LJTK093414
Mar 15, 2018Smiths Medical ASD Inc.
PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1/EA); b. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO (1/EA); c. DL, LP, PU, 3.2MM, WING-LOCK, 10FR/INTRO
Terminated
LJTK973862
K974471
Feb 8, 2018Bard Peripheral Vascular Inc
POWERPORT ClearVUE Slim Implantable Port with Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00005
Completed
LJTK122899
Feb 8, 2018Bard Peripheral Vascular Inc
POWERPORT ClearVUE isp Implantable Port With Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00004
Completed
LJTK063377
Feb 8, 2018Bard Peripheral Vascular Inc
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678301
Completed
LJTK122899
Feb 8, 2018Bard Peripheral Vascular Inc
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678300
Completed
LJTK122899
Feb 8, 2018Bard Peripheral Vascular Inc
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter with Open Suture Holes, REF 5676301
Completed
LJTK122899
Feb 8, 2018Bard Peripheral Vascular Inc
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 5676300
Completed
LJTK122899
Feb 8, 2018Bard Peripheral Vascular Inc
POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 5668362
Completed
LJTK063377

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