ClearanceBrief
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)
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Top companies in LJS

DateFirm and productCodeLinked 510(k)
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 26, 2012Angiodynamics 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
LJSK093406
Jan 11, 2012Angiodynamics 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
LJSK030415
Jul 11, 2011Bard 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
LJSK051417
Jun 29, 2011Vygon Corporation
LIFECATH S PICC with Microflash Introducer Catheter, Percutaneous, Intravascular Product Code 2296.214 Product Usage: Intravascular catheter
Terminated
LJSK062425
Jun 29, 2011Vygon Corporation
LIFECATH S PICC Catheter, Percutaneous, Intravascular Product Code 2296.211 Product Usage:: Intravascular catheter
Terminated
LJSK062425
Feb 23, 2011Cook, 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
LJSK072625
Feb 23, 2011Cook, 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
LJSK072625
Feb 23, 2011Cook, 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
LJSK072625
Feb 23, 2011Cook, 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
LJSK072625
Feb 23, 2011Cook, 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
LJSK072625
Feb 23, 2011Cook, 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
LJSK072625
Feb 23, 2011Cook, 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
LJSK072625
Feb 23, 2011Cook, 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
LJSK072625
Feb 23, 2011Cook, 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
LJSK072625
Feb 23, 2011Cook, 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
LJSNone listed
Jan 6, 2011Bard 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
LJSK926331
May 26, 2010Arrow 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
LJSK061289
K073451
Jun 24, 2009Arrow International Inc
Arrow Peripherally Inserted Central Catheter
Terminated
LJSK042126
Sep 16, 2008Medical 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
LJSK053345
Mar 16, 2006Bard Access Systems, Inc
Groshong NXT 5 Fr. Dual-Lumen Reverse Taper PICC
Terminated
LJSK023374
K034020
Mar 16, 2006Bard Access Systems, Inc
Groshong NXT 5 Fr. Dual-Lumen Reverse Taper PICC.
Terminated
LJSK023374
K034020
Mar 16, 2006Bard Access Systems, Inc
Groshong NXT ClearVue 4 Fr. Single-Lumen PICC, Bard Access Systems, Inc.
Terminated
LJSK023374
K034020
Mar 16, 2006Bard Access Systems, Inc
Groshong NXT ClearVue 4 Fr Single-Lumen PICC, Bard Access Systems, Inc.
Terminated
LJSK023374
K034020
Jan 6, 2006Boston 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
LJSK991897
Jan 6, 2006Boston 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
LJSK991897
Jan 6, 2006Boston 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
LJSK962300
Jan 6, 2006Boston 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
LJSK962300
Jan 6, 2006Boston 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
LJSK954258
Dec 15, 2005Becton Dickinson Medical Systems
16 G / 5F Dual Lumen L-Cath complete kit with U-Wing
Terminated
LJSK920755
Dec 15, 2005Becton Dickinson Medical Systems
16 G / 5F Dual Lumen L-Cath Basic Kit with U-Wing
Terminated
LJSK920755
Dec 15, 2005Becton Dickinson Medical Systems
16 G / 5F Dual Lumen L-Cath Complete Kit with Introsyte
Terminated
LJSK920755
Dec 15, 2005Becton Dickinson Medical Systems
16 G / 5F Dual Lumen L-Cath Basic Kit with Introsyte
Terminated
LJSK920755
Dec 15, 2005Becton Dickinson Medical Systems
16 G / 5F Dual Lumen L-Cath Complete Kit with Introsyte Autoguard
Terminated
LJSK920755
Dec 15, 2005Becton Dickinson Medical Systems
16 G / 5F Dual Lumen L-Cath Basic Kit with Insyte Autoguard
Terminated
LJSK920755
Dec 15, 2005Becton Dickinson Medical Systems
16 G / 5F Dual Lumen L-Cath catheter only.
Terminated
LJSK920755
Oct 28, 2005Medical Components, Inc dba MedComp
Jet Medical 4F Single Lumen PICC Kit. Catalog number JP7-4
Terminated
LJSK003682

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