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)
Top companies in LJT
| Company | 510(k)s | Recalls |
|---|---|---|
| Bard Peripheral Vascular, Inc. | 1 | 30 |
| Strato Medical Corp. | 27 | 0 |
| Therex Corp. | 24 | 0 |
| C.R. Bard, Inc. | 22 | 0 |
| ARROW INTERNATIONAL, LLC | 0 | 19 |
| Smiths Medical Asd, Inc. | 1 | 18 |
| Deltec, Inc | 0 | 18 |
| Navilyst Medical, Inc. | 4 | 14 |
| Med Institute, Inc. | 17 | 0 |
| Boston Scientific Corp | 8 | 8 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
PICC ACCESS TRAY/ASK-04001-CG1 Open, Classified |
LJT | K003006 |
| Sep 5, 2025 | B.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 |
LJT | K130576 K952435 |
| Mar 18, 2025 | Smiths 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 |
LJT | K994216 |
| Mar 18, 2025 | Smiths 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 |
LJT | K994216 |
| Mar 18, 2025 | Smiths Medical ASD, Inc. smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24 Open, Classified |
LJT | None listed |
| Mar 18, 2025 | Smiths 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 |
LJT | None listed |
| Mar 18, 2025 | Smiths 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 |
LJT | None listed |
| Mar 18, 2025 | Smiths 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 |
LJT | K994216 |
| Mar 18, 2025 | Smiths 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 |
LJT | K994216 |
| Mar 18, 2025 | Smiths 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 |
LJT | K994216 |
| Mar 18, 2025 | Smiths 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 |
LJT | K994216 |
| Mar 18, 2025 | Smiths 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 |
LJT | None listed |
| Mar 18, 2025 | Smiths 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 |
LJT | None listed |
| Mar 18, 2025 | Smiths 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 |
LJT | None listed |
| Oct 25, 2022 | Angiodynamics, 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 |
LJT | K033473 |
| Mar 25, 2021 | Bard 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 |
LJT | K090512 |
| Mar 25, 2021 | Bard 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 |
LJT | K090512 |
| Mar 25, 2021 | Bard 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 |
LJT | K090512 |
| Mar 8, 2021 | Medical 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 |
LJT | K132177 |
| Feb 22, 2021 | Angiodynamics 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 |
LJT | K062414 |
| Jun 11, 2020 | Smiths Medical ASD Inc. PORT-A-CATH II POWER P.A.C. Low Profile" system. Terminated |
LJT | K072657 |
| Jan 15, 2020 | Bard 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 |
LJT | K122899 |
| Oct 1, 2019 | Bard 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 |
LJT | K163001 |
| Oct 1, 2019 | Bard 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 |
LJT | K022983 |
| Oct 1, 2019 | Bard 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 |
LJT | K873213 |
| Oct 1, 2019 | Bard 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 |
LJT | K873213 |
| Oct 1, 2019 | Bard 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 |
LJT | K050310 |
| Oct 1, 2019 | Bard 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 |
LJT | K860256 |
| Oct 1, 2019 | Bard 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 |
LJT | K072549 |
| Oct 1, 2019 | Bard 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 |
LJT | K073423 |
| Oct 1, 2019 | Bard 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 |
LJT | K073423 |
| Oct 1, 2019 | Bard 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 |
LJT | K073423 |
| Sep 18, 2019 | Angiodynamics 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 |
LJT | K122767 |
| Sep 18, 2019 | Angiodynamics Inc. (Navilyst Medical Inc.) BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022 Terminated |
LJT | K122767 |
| Sep 18, 2019 | Angiodynamics 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 |
LJT | K122767 |
| Sep 18, 2019 | Angiodynamics 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 |
LJT | K122767 |
| Sep 18, 2019 | Angiodynamics 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 |
LJT | K122767 |
| Jul 8, 2019 | Smiths 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 |
LJT | K072657 |
| Feb 14, 2019 | Bard Peripheral Vascular Inc PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Open, Classified |
LJT | K063377 |
| Jul 24, 2018 | Angiodynamics 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 |
LJT | K131694 |
| Jun 25, 2018 | Bard 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 |
LJT | K063377 K122899 |
| Mar 15, 2018 | Smiths 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 |
LJT | K093414 |
| Mar 15, 2018 | Smiths 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 |
LJT | K973862 K974471 |
| Feb 8, 2018 | Bard 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 |
LJT | K122899 |
| Feb 8, 2018 | Bard 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 |
LJT | K063377 |
| Feb 8, 2018 | Bard Peripheral Vascular Inc POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678301 Completed |
LJT | K122899 |
| Feb 8, 2018 | Bard Peripheral Vascular Inc POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678300 Completed |
LJT | K122899 |
| Feb 8, 2018 | Bard Peripheral Vascular Inc POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter with Open Suture Holes, REF 5676301 Completed |
LJT | K122899 |
| Feb 8, 2018 | Bard Peripheral Vascular Inc POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 5676300 Completed |
LJT | K122899 |
| Feb 8, 2018 | Bard Peripheral Vascular Inc POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 5668362 Completed |
LJT | K063377 |
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