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) |
|---|---|---|---|
| Nov 4, 2015 | Arrow International Inc ARROW PICC Kit featuring Chlorag+ard Technology
Midline Catheterization Kit
ARROW Advantage5 Pressure Injectable PICC Kit
Arrow Pressure Injectable Arrow PICC powered by Arrow VPS Stylet
ARROW Pressur Terminated |
LJS | K112896 K113277 +3 |
| Oct 15, 2015 | Arrow International Inc 4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-term use greater than 30 days. Terminated |
LJS | K061289 K073451 |
| Sep 23, 2015 | Bard Access Systems Marketing brochures for the PowerPICC and PowerPICC SOLO catheters Terminated |
LJS | None listed |
| Aug 25, 2015 | Arrow International Inc PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound
Product Usage:
catheter, intravascular, therapeutic, ultrasound Terminated |
LJS | K042126 K061289 +4 |
| Jul 8, 2015 | Bard Access Systems PowerPICC SOLO2 Catheter 4F Maximal Barrier Tray with Microintroducer (Single-Lumen) (Sherlock)
The PowerPICC Solo catheters are intended for short or long term peripheral access to the central ve Terminated |
LJS | K072230 K091324 |
| Jul 8, 2015 | Bard Access Systems PowerPICC SOLO Catheter with Tip Location System (TLS) Stylet 4F Nurse Full Tray with Microintroducer (with Lidocain)
The PowerPICC Solo catheters are intended for short or long term peripheral acc Terminated |
LJS | K072230 K091324 |
| Jul 8, 2015 | Bard Access Systems PowerPICC SOLO Catheter with Sherlock 3CG (TPS) Stylet 5F Maximal Barrier Tray with Microintroducer
The PowerPICC Solo catheters are intended for short or long term peripheral access to the central Terminated |
LJS | K072230 K091324 |
| Jul 8, 2015 | Bard Access Systems PowerPICC SOLO Catheter with Sherlock 3CG TPS Stylet 4F Maximal Barrier Tray with Microintroducer
The PowerPICC Solo catheters are intended for short or long term peripheral access to the central v Terminated |
LJS | K072230 K091324 |
| Mar 13, 2015 | Bard Access Systems BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Bard Poly Midline 3F Full Tray (Single-Lumen) (with Microintroducer), Bard Poly Midline 3F Maximal Barrier Tray (Single-L Terminated |
LJS | K001901 K023374 +2 |
| Dec 12, 2014 | Pfm Medical Inc ASEPT Peritoneal Drainage System, Ref No. P09080002
Product Usage: The pfm medical ASEPT Peritoneal Drainage System is a tunneled, indwelling catheter used to drain accumulated fluid from the abdome Terminated |
LJS | K083873 |
| Dec 12, 2014 | Pfm Medical Inc 6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D
Product Usage:The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and Terminated |
LJS | K083873 |
| Dec 12, 2014 | Pfm Medical Inc Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005
Product Usage: These introducers are used for the percutaneous introduction of therapeutic devices, such as PICCS. The PFM CT PICC cathete Terminated |
LJS | K083873 |
| Oct 7, 2014 | Navilyst Medical, Inc PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M0224751, REF/Catalog No. 60M022475, STERILE ---
Indicated for Terminated |
LJS | K042061 K121990 +1 |
| Oct 7, 2014 | Navilyst Medical, Inc PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M0367051, REF/Catalog No. 60M036705, STERILE ---
Intended for short or long ter Terminated |
LJS | K042061 K121990 +1 |
| Oct 7, 2014 | Navilyst Medical, Inc PICC Convenience Kit with Accessories, BioFlo Hybrid PICC, 6F-55 cm TRIPLE LUMEN, UPN Product No. H96560M0367061, REF/Catalog No. 60M036706, STERILE ---
Indicated short or long-term peripheral acce Terminated |
LJS | K042061 K121990 +1 |
| Oct 7, 2014 | Navilyst Medical, Inc PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M0501981, REF/Catalog No. 60M050198, STERILE ---
Intended for Terminated |
LJS | K042061 K121990 +1 |
| Oct 7, 2014 | Navilyst Medical, Inc PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M1318471, REF/Catalog No. 60M131847, STERILE ---
Intended for short or long ter Terminated |
LJS | K042061 K121990 +1 |
| Oct 7, 2014 | Navilyst Medical, Inc PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 5F-55 cm SINGLE LUMEN, UPN Product No. H96560M1406071, REF/Catalog No. 60M140607, STERILE --- Navilyst Medical Terminated |
LJS | K042061 K121990 +1 |
| Oct 7, 2014 | Navilyst Medical, Inc PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M1841541, REF/Catalog No. 60M184154, STERILE --- Navilyst Medical Terminated |
LJS | K042061 K121990 +1 |
| Oct 7, 2014 | Navilyst Medical, Inc PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 5F-55 cm SINGLE LUMEN, UPN Product No. H96560M2309831, REF/Catalog No. 60M230983, STERILE ---
Indicated for Terminated |
LJS | K042061 K121990 +1 |
| Oct 7, 2014 | Navilyst Medical, Inc BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 4F-55 cm, UPN Product No. H965750121, REF/Catalog No. 75-012, STERILE ---
Intended for short or long term peripheral access to the cent Terminated |
LJS | K042061 K121990 +1 |
| Oct 7, 2014 | Navilyst Medical, Inc BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750141, REF/Catalog No. 75-014, STERILE ---
Intended for short or long term peripheral access to the cen Terminated |
LJS | K042061 K121990 +1 |
| Oct 7, 2014 | Navilyst Medical, Inc BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750191, REF/Catalog No. 75-019, STERILE ---
Indicated for short or long-term p Terminated |
LJS | K042061 K121990 +1 |
| Oct 7, 2014 | Navilyst Medical, Inc BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 3F-55 cm, UPN Product No. H965750231, REF/Catalog No. 75-023, STERILE ---
Intended for short or long term peripheral access to the ce Terminated |
LJS | K042061 K121990 +1 |
| Apr 24, 2014 | Arrow International Inc Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number CDC-35052-VPS, peripherally inserted central catheter. Terminated |
LJS | K121941 |
| Mar 11, 2013 | Vygon Corporation Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Components, Peripherally Inserted Central Catheter. Terminated |
LJS | K081904 |
| Feb 28, 2013 | Medical Components, Inc dba MedComp REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components
Product Usage: Power injectable infusion PICC insertion kits Terminated |
LJS | K081904 |
| Feb 21, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics SPECIAL ORDER Morpheus Smart PICC CT --- 4F Single Lumen 65cm --- Max CT Flow Rate: 4mL/sec --- Kit Contains: --- 1 each Nitinol Guidewire, 0.46mm (0.018in.) x 130cm --- Catalog No. [REF Terminated |
LJS | K093406 |
| Feb 21, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics SPECIAL ORDER Morpheus Smart PICC CT --- 5F Dual Lumen 65cm --- Max CT Flow Rate: 4mL/sec --- Kit Contains: --- 1 each Nitinol Guidewire, 0.46mm (0.018in.) x 130cm --- Catalog No. [REF] Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Special Order Morpheus Smart PICC CT 65cm 5F Dual Lumen with Reverse Taper --- Max CT Flow Rate: 4mL/sec --- Injector Pressure Limit --- Catalog No.: 52102638--- Made in the USA --- [Man Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Special Order Morpheus Smart PICC CT 65cm 6F Dual Lumen with Reverse Taper --- Max CT Flow Rate: 6mL/sec --- Injector Pressure Limit --- Catalog No.: 52102624 --- Made in the USA --- [Ma Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Special Order Morpheus Smart PICC CT 65cm 5F Dual Lumen with Reverse Taper --- Max CT Flow Rate: 4mL/sec --- Injector Pressure Limit --- Catalog No.: 52102618 --- Made in the USA --- [Ma Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Special Order Morpheus Smart PICC CT 65cm 5F Dual Lumen with Reverse Taper --- Max CT Flow Rate: 4mL/sec --- Injector Pressure Limit --- Catalog No.: 52100602 --- Made in the USA --- [Ma Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 6F Triple Lumen w/ Reverse Taper 55cm --- Max CT Flow Rate: 5mL/sec --- Catalog No.: 12110941 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804 Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT with Stylet 5F Dual Lumen w/ Reverse Taper 55cm --- Max CT Flow Rate: 5mL/sec --- Catalog No.: 12110937 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen w/ Reverse Taper 55cm --- Max CT Flow Rate: 5mL/sec --- Catalog No.: 12110936 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804 -- Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen w/ Reverse Taper 65cm --- Max CT Flow Rate: 4mL/sec --- Catalog No.: 12110934 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804 -- Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT with Stylet 5F Dual Lumen w/ Reverse Taper 65cm --- Max CT Flow Rate: 4mL/sec --- Catalog No.: 12110929 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT with Stylet 5F Dual Lumen 65cm --- Max CT Flow Rate: 4mL/sec --- Catalog No.: 12110923 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804 --- Ass Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen w/ Reverse Taper 65cm --- Max CT Flow Rate: 4mL/sec --- Catalog No.: 12110919 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804 -- Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 6F Dual Lumen w/ Reverse Taper 65cm --- Max CT Flow Rate: 6mL/sec --- Catalog No.: 12110918 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804 -- Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen w/ Reverse Taper 65cm --- Max CT Flow Rate: 4mL/sec --- Catalog No.: 12110917 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804 -- Terminated |
LJS | K093406 |
| Jan 26, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen 65cm --- Max CT Flow Rate: 4mL/SEC --- Catalog No.: 12110904 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804 --- Assembled and P 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] 12104830 --- 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] 12104821 --- 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] 12104814 --- 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] 12104813 --- 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] 12104805 --- Made in the USA --- [Manufacturing symbol] 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] 12104612 --- 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] 12104606 --- Made in the USA --- [Ma Terminated |
LJS | K093406 |
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