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) |
|---|---|---|---|
| Dec 19, 2006 | Arrow International Inc Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter.
Latex-Free A Port. 9 Fr. Introducer Kit
Ref Product No. AP-06013. Terminated |
LJT | K875214 K921475 |
| Dec 19, 2006 | Arrow International Inc Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter.
Latex-Free A Port. 6 Fr. Introducer Kit.
Ref Product No. AP-06014 Terminated |
LJT | K921379 K926011 |
| Dec 19, 2006 | Arrow International Inc Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter.
Latex-free A Port. 10 Fr. Introducer Kit.
Ref. Product No. AP-06015 Terminated |
LJT | K875214 K921475 |
| Dec 19, 2006 | Arrow International Inc Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter.
Latex-Free Low Profile Port. 6 Fr. Introducer Kit.
Ref. Product No. AP-06016. Terminated |
LJT | K790882 K925373 |
| Dec 19, 2006 | Arrow International Inc Implantable Vascular Access system --Infusion Ports with Silicone Rubber Catheter.
Latex-free A Port. 9 Fr. Introducer Kit.
Ref. Product No. AP-06018. Terminated |
LJT | K922434 K926011 |
| Dec 19, 2006 | Arrow International Inc Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter.
Latex-Free Low Profile Port. 9 Fr. Introducer Kit
Ref Product No. AP-06020 Terminated |
LJT | K790882 K933350 |
| Dec 19, 2006 | Arrow International Inc Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter.
Latex-Free Low Profile Port. 10 Fr. Introducer Kit
Ref Product No. AP-06022 Terminated |
LJT | K790882 K933316 |
| Dec 19, 2006 | Arrow International Inc Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter.
Latex-Free Low Profile Port. 6 Fr. Introducer Kit
Ref. Product No. AP-06036 Terminated |
LJT | K790882 K934792 |
| Dec 19, 2006 | Arrow International Inc Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter.
Latex-Free Low Profile Port. 9 Fr. Introducer Kit.
Ref Product No. AP -06040 Terminated |
LJT | K790882 K942412 |
| Dec 19, 2006 | Arrow International Inc Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter.
Latex-Free Low Profile Port. 10 Fr. Introducer Kit.
Ref Product No. AP-06042. Terminated |
LJT | K790882 K934802 |
| Dec 19, 2006 | Arrow International Inc Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter.
Latex-Free Low Profile B Port, 6 Fr. Introducer Kit.
Ref Product No. AP-06046 Terminated |
LJT | K960572 |
| Dec 19, 2006 | Arrow International Inc Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter.
Latex-Free A Port, 10 Fr. Introducer Kit.
Ref Product No. AP-06520 Terminated |
LJT | K882230 K921475 |
| Dec 19, 2006 | Arrow International Inc Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter.
Latex-Free A(2) Port , 12 Fr. Introducer Kit.
Ref Product Code: AP-06528 Terminated |
LJT | K790882 K911055 |
| Dec 19, 2006 | Arrow International Inc Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter.
Latex-Free A(2) Port, 10 Fr. Introducer Kit
Ref Product No. AP-06530 Terminated |
LJT | K790882 K950212 |
| Dec 19, 2006 | Arrow International Inc Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter.
Latex-Free A(2) Port, 17 Fr. Introducer Kit
REF Product No. AP-06535 Terminated |
LJT | K955819 |
| Dec 19, 2006 | Arrow International Inc Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter.
Ref Product No. AP-01013
Latex-Free Low Profile Port Terminated |
LJT | K932447 |
| Dec 19, 2006 | Arrow International Inc Implantable Vascular Access System -- Infusion Ports with Silicone Rubber catheter.
Latex Free A Port
Ref Product No. AP-01007. Terminated |
LJT | K903691 |
| Jan 28, 2005 | Smiths Medical MD, Inc. Deltec branded PORT-A-CATH II Single-Lumen Low Profile Polysulfone/Titanium Venous Access System, Pre-assembled with PolyFlow, Ployurethane Catheter, 2.6 mm (7.8 Fr) O.D. x 1.6 mm I.D., 8.5 Fr Introdu Terminated |
LJT | K942024 |
| Nov 24, 2004 | Horizon Medical Products Inc LifePort, Dual Lumen Profile Plastic Dual Port with Poly Urethane Catheter Kit, Product Code/REF: LPS 7255, Manufactured by: Horizon Medical Products, Inc., One Horizon Way, P.O. Box 627, Manchester, Terminated |
LJT | K953529 |
| Jul 20, 2004 | Deltec, Inc Port-A-Cath II Dual-lumen Low Profile Polysulfone/Titanium Venous Access System, with Dual-lumen PolyFlow Polyurethane Catheter, 3.2mm O.D. x 1.4mm I.D., 10 French Introducer Set, REF 21-8068-24 Terminated |
LJT | K974471 |
| Jul 20, 2004 | Deltec, Inc Port-A-Cath II Dual-lumen Low Profile Polysulfone/Titanium Venous Access System, with Dual-lumen PolyFlow Polyurethane Catheter, 2.2mm O.D. x 1.0mm I.D., 7 French Introducer Set, REF 21-8066-24 Terminated |
LJT | K974471 |
| Jul 20, 2004 | Deltec, Inc Port-A-Cath II Fluoro-Free Low Profile Venous Access System, with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., and with CATH-FINDER Sensor Wire, REF 21-4685-24 Terminated |
LJT | K962695 |
| Jul 20, 2004 | Deltec, Inc Port-A-Cath P.A.S. Port T2 Titanium Venous Access System, with PolyFlow Polyurethane Catheter, 1.9mm O.D. x 1.0mm I.D., 6 French Introducer Set, REF 21-4573-24 Terminated |
LJT | K994216 |
| Jul 20, 2004 | Deltec, Inc ProPort Low Profile Plastic Venous Access System, with PolyFlow Polyurethane Catheter, 1.9mm O.D. x 1.0mm I.D., 6 French Introducer Set, REF 21-4183-24 Terminated |
LJT | K994216 |
| Jul 20, 2004 | Deltec, Inc ProPort Low Profile Plastic Venous Access System, with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 French Introducer Set, REF 21-4171-24 Terminated |
LJT | K994216 |
| Jul 20, 2004 | Deltec, Inc ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 French Introducer Set, REF 21-4165-24 Terminated |
LJT | K994216 |
| Jul 20, 2004 | Deltec, Inc ProPort Plastic Venous Access System, with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 French Introducer Set, REF 21-4155-24 Terminated |
LJT | K994216 |
| Jul 20, 2004 | Deltec, Inc Port-A-Cath II Low Profile Polysulfone/Titanium Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 1.9mm O.D. x 1.0mm I.D., 6 Fr Introducer Set, REF 21-4085-24 Terminated |
LJT | K962695 |
| Jul 20, 2004 | Deltec, Inc Port-A-Cath II Low Profile Polysulfone/Titanium Venous Access System, with PolyFlow Polyurethane Catheter, 1.9mm O.D. x 1.0mm I.D., 6 Fr Introducer Set, REF 21-4083-24 Terminated |
LJT | K962695 |
| Jul 20, 2004 | Deltec, Inc Port-A-Cath II Low Profile Polysulfone/Titanium Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 Fr Introducer Set, REF 21-4073-24 Terminated |
LJT | K962695 |
| Jul 20, 2004 | Deltec, Inc Port-A-Cath II Low Profile Polysulfone/Titanium Venous Access System, with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 Fr Introducer Set, REF 21-4071-24 Terminated |
LJT | K962695 |
| Jul 20, 2004 | Deltec, Inc Port-A-Cath II Polysulfone/Titanium Venous Access System, with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 Fr Introducer Set, REF 21-4055-24 Terminated |
LJT | K962695 |
| Jul 20, 2004 | Deltec, Inc Port-A-Cath II Polysulfone/Titanium Venous Access System, with Silicone Catheter, 2.8mm O.D. x 1.0mm I.D., 9 Fr Introducer Set, REF 21-4051-24 Terminated |
LJT | K932840 |
| Jul 20, 2004 | Deltec, Inc Port-A-Cath Low Profile Titanium Venous Access System, with PolyFlow Polyurethane Catheter, 1.9mm O.D. x 1.0mm I.D., 6 Fr Introducer Set, REF 21-4037-24 Terminated |
LJT | K973862 |
| Jul 20, 2004 | Deltec, Inc Port-A-Cath Low Profile Titanium Venous Access System, with Silicone Catheter, 2.8mm O.D. x 1.0mm I.D., 9 Fr Introducer Set, REF 21-4035-24 Terminated |
LJT | K973862 |
| Jul 20, 2004 | Deltec, Inc Port-A-Cath Titanium Venous Access System, with Silicone Catheter, 2.8mm O.D. x 1.0mm I.D., 9 Fr Introducer Set, REF 21-4009-24 Terminated |
LJT | None listed |
| Jul 20, 2004 | Deltec, Inc Port-A-Cath Titanium Venous Access System, with Silicone Catheter, 2.8mm O.D. x 1.0mm I.D., 9 Fr Introducer Set, REF 21-4003-24 Terminated |
LJT | None listed |
| Jul 20, 2004 | Boston Scientific Corporation Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, STD PS port, Implantable Port System, Model # M001453660, Catalog #45-366 Terminated |
LJT | K030083 |
| Jul 20, 2004 | Boston Scientific Corporation Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, Low Profile PS port, Implantable Port System, Model # M001452380, Catalog #45-238 Terminated |
LJT | K031844 |
| Jul 20, 2004 | Boston Scientific Corporation Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, STD Titanium Port, Implantable Port System, Model # M001453620, Catalog #45-362 Terminated |
LJT | K030083 |
| Jul 20, 2004 | Boston Scientific Corporation Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, Mini Titanium port, Implantable Port System, Model # M001452150, Catalog #45-215 Terminated |
LJT | K030083 |
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