Panels › General Hospital › Product code LJS · Class 2
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Regulation 880.5970
4510(k)s in 12 months (303 all time)
9recalls in 12 months (332 all time)
305recalls that name a 510(k)
Top companies in LJS
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12104605 --- Made in the USA --- [Ma Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102829 --- Made in the USA --- [Manufacturing symbol] Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102821 --- Made in the USA --- [Manufacturing symbol] Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102813 --- Made in the USA --- [Manufacturing symbol] Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102812 --- Made in the USA --- [Manufacturing symbol] Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen --- Max CT Flow Rate: 6mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102806 --- Made in the USA --- [Manufacturing symbol] Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102805 --- Made in the USA --- [Manufacturing symbol] Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 55cm 6F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 5mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102617 --- Made in the USA --- [Ma Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 55cm 5F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 5mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102616 --- Made in the USA --- [Ma Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 6mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102613 --- Made in the USA --- [Ma Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102611 --- Made in the USA --- [Ma Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 6mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102606 --- Made in the USA --- [Ma Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102605 --- Made in the USA --- [Ma Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102604 --- Made in the USA --- [Ma Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4 mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12100805 --- Made in the USA --- [Manufacturing symbol Terminated |
LJS | K093406 |
| Jan 11, 2012 | Angiodynamics Worldwide Headquarters MORPHEUS CT PICC with STYLET, 5F Dual Lumen 65 cm Insertion Kit, Catalog No./REF 1200923, STERILE, AngioDynamics Queensbury, NY 12804 USA --- COMMON/USUAL NAME: Percutaneous, implanted, long-term int Terminated |
LJS | K030415 |
| Jul 11, 2011 | Bard Access Systems Bard PowerLine 6 Fr. Dual-Lumen Polyurethane Catheter with SureCuff Ingrowth Cuff, REF 0700610, Sterile, Contents...1 Each - PTFE Introducer and Dilator, 6.5 FR. x 10 cm..., Assembled in Mexico.
Pro Terminated |
LJS | K051417 |
| Jun 29, 2011 | Vygon Corporation LIFECATH S PICC with Microflash Introducer
Catheter, Percutaneous, Intravascular
Product Code 2296.214
Product Usage: Intravascular catheter Terminated |
LJS | K062425 |
| Jun 29, 2011 | Vygon Corporation LIFECATH S PICC
Catheter, Percutaneous, Intravascular
Product Code 2296.211
Product Usage:: Intravascular catheter Terminated |
LJS | K062425 |
| Feb 23, 2011 | Cook, Inc. Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous Catheter,
4.0 Fr/ 60 cm, UPICDSY-4.0-CT-NT, G49181, Sterile, Cook Medical, Cook Incorporated, Bloomingt Terminated |
LJS | K072625 |
| Feb 23, 2011 | Cook, Inc. Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous Catheter,
4.0 Fr/ 60 cm, UPICDSY-4.0-CT, G49180, Sterile, Cook Medical, Cook Incorporated, Bloomington, Terminated |
LJS | K072625 |
| Feb 23, 2011 | Cook, Inc. Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous Catheter, ,
4.0 Fr/ 60 cm, UPICSY-4.0-CT-OTW, G49176, Sterile, Cook Medical, Cook Incorporated, Blooming Terminated |
LJS | K072625 |
| Feb 23, 2011 | Cook, Inc. Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous Catheter,
4.0 Fr/ 60 cm, UPICSY-4.0-CT-NT, G49175, Sterile, Cook Medical, Cook Incorporated, Bloomington Terminated |
LJS | K072625 |
| Feb 23, 2011 | Cook, Inc. Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous Catheter,
5.0 Fr/ 9 cm, UPICDSY-5.0-CT-OTW, G49170, Sterile, Cook Medical, Cook Incorporated, Bloomingto Terminated |
LJS | K072625 |
| Feb 23, 2011 | Cook, Inc. Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous Catheter,
5.0 Fr/ 60 cm, UPICDSY-5.0-CT-NT, G49169, Sterile, Cook Medical, Cook Incorporated, Bloomingto Terminated |
LJS | K072625 |
| Feb 23, 2011 | Cook, Inc. Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous Catheter, ,
5.0 Fr/ 60 cm, UPICDSY-5.0-CT, G49168, Sterile, Cook Medical, Cook Incorporated, Bloomingto Terminated |
LJS | K072625 |
| Feb 23, 2011 | Cook, Inc. Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous Catheter,
5.0 Fr/ 60 cm, UPICSY-5.0-CT-OTW, G49164, Sterile, Cook Medical, Cook Incorporated, Bloomingt Terminated |
LJS | K072625 |
| Feb 23, 2011 | Cook, Inc. Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous Catheter,
5.0 Fr/ 60 cm, UPICSY-5.0-CT-NT, G49163, Sterile, Cook Medical, Cook Incorporated, Bloomington Terminated |
LJS | K072625 |
| Feb 23, 2011 | Cook, Inc. Arterial Pressure Monitoring Tray, 2.5 Fr/ 2.5 cm Polyethylene Catheter,C-PMSY-250-HOPKINS, G44036, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN. Terminated |
LJS | None listed |
| Jan 6, 2011 | Bard Access Systems Groshong 3 Fr. Single-Lumen PICC Intermediate Tray with Safety Introducer, Reorder Number 7717300, Bard Access Systems, Inc., Salt Lake City, UT 84116.
The Groshong is a family of single and dual -lum Terminated |
LJS | K926331 |
| May 26, 2010 | Arrow International Inc Arrow 4FR Peripherally Inserted Central Catheter (PICCs) Kits. Product numbers: ASK-01451-BMH; ASK-05041-CHC; ASK-05041-CHC1; ASK-05041-CHM; ASK-05041-HMC; ASK-05041-QV; ASK-07041-BMH; CN-05041-LW; Terminated |
LJS | K061289 K073451 |
| Jun 24, 2009 | Arrow International Inc Arrow Peripherally Inserted Central Catheter Terminated |
LJS | K042126 |
| Sep 16, 2008 | Medical Components, Inc dba MedComp USCT5D, Pro-PICC CT 5F x 55 cm Dual Lumen. infusion catheter insertion kit. The product is shipped 5 units per box and is indicated for short and long term access to the central venous system. Terminated |
LJS | K053345 |
| Mar 16, 2006 | Bard Access Systems, Inc Groshong NXT 5 Fr. Dual-Lumen Reverse Taper PICC Terminated |
LJS | K023374 K034020 |
| Mar 16, 2006 | Bard Access Systems, Inc Groshong NXT 5 Fr. Dual-Lumen Reverse Taper PICC. Terminated |
LJS | K023374 K034020 |
| Mar 16, 2006 | Bard Access Systems, Inc Groshong NXT ClearVue 4 Fr. Single-Lumen PICC, Bard Access Systems, Inc. Terminated |
LJS | K023374 K034020 |
| Mar 16, 2006 | Bard Access Systems, Inc Groshong NXT ClearVue 4 Fr Single-Lumen PICC, Bard Access Systems, Inc. Terminated |
LJS | K023374 K034020 |
| Jan 6, 2006 | Boston Scientific Corporation Implantable Chest Ports labeled: Titanium Single Lumen Port with PASV Valve and 6.6F Silicone Catheter. Boston Scientific Cat. # PRTA66A M001PRTA66AO. Firm on label: Boston Scientific, Natick, Terminated |
LJS | K991897 |
| Jan 6, 2006 | Boston Scientific Corporation Implantable Chest Ports labeled: Titanium Single Lumen Port with PASV valve and 6.6F Silicone Catheter. Boston Scientific Cat. # PRTA66P M001PRTA66P0. Firm on label: Boston Scientific Natick, MA a Terminated |
LJS | K991897 |
| Jan 6, 2006 | Boston Scientific Corporation Silicone Central Venous Catheters with PASV Valve and Polyester Cuff - 7F. Boston Scientific Cat. #CVC702IK, M001CVC702IKO. Firm on label: Boston Scientific *** Manufactured at: 10 Glens Falls Tech Terminated |
LJS | K962300 |
| Jan 6, 2006 | Boston Scientific Corporation Silicone Central Venous Catheter with PASV Valve and Polyester Cuff - 6.6F. Boston Scientific Cat. #CVC661IK M001CVC661IK0. Firm on label: Boston Scientific Corporation, NAMIC Technology Center, G Terminated |
LJS | K962300 |
| Jan 6, 2006 | Boston Scientific Corporation Vaxcel Implantable Vascular Access System - Titanium Mini Port with 7F Polyurethane Catheter. Boston Scientific Catalog # 45-305, M001453050. Firm on label: Boston Scientific/Medi-Tech, Watertown, Terminated |
LJS | K954258 |
| Dec 15, 2005 | Becton Dickinson Medical Systems 16 G / 5F Dual Lumen L-Cath complete kit with U-Wing Terminated |
LJS | K920755 |
| Dec 15, 2005 | Becton Dickinson Medical Systems 16 G / 5F Dual Lumen L-Cath Basic Kit with U-Wing Terminated |
LJS | K920755 |
| Dec 15, 2005 | Becton Dickinson Medical Systems 16 G / 5F Dual Lumen L-Cath Complete Kit with Introsyte Terminated |
LJS | K920755 |
| Dec 15, 2005 | Becton Dickinson Medical Systems 16 G / 5F Dual Lumen L-Cath Basic Kit with Introsyte Terminated |
LJS | K920755 |
| Dec 15, 2005 | Becton Dickinson Medical Systems 16 G / 5F Dual Lumen L-Cath Complete Kit with Introsyte Autoguard Terminated |
LJS | K920755 |
| Dec 15, 2005 | Becton Dickinson Medical Systems 16 G / 5F Dual Lumen L-Cath Basic Kit with Insyte Autoguard Terminated |
LJS | K920755 |
| Dec 15, 2005 | Becton Dickinson Medical Systems 16 G / 5F Dual Lumen L-Cath catheter only. Terminated |
LJS | K920755 |
| Oct 28, 2005 | Medical Components, Inc dba MedComp Jet Medical 4F Single Lumen PICC Kit. Catalog number JP7-4 Terminated |
LJS | K003682 |
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