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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)
Oct 28, 2005Medical Components, Inc dba MedComp
Jet Medical 4F x 60cm Single Lumen Polyurethane PICC Nursing Tray. Catalog number JDMPN4S-T
Terminated
LJSK003682
Oct 28, 2005Vygon Corporation
Premicath 28G PICC Catheter
Terminated
LJSK041468
Aug 10, 2005Boston Scientific Corporation
PASV Central Venous Catheter, 7F, Cat. # CVC702IK, Model # M0001CVC702IK. The 7Fr PASV Central Venous Catheter is a packaged configuration comprised of a silicone Central Venous Catheter with PASV V
Terminated
LJSK963806
Aug 6, 2005United States Surgical Corporation
ChemoSite Implantable venous access sytem with printed Polyurethane Catheter and 7 French Introducer Kit Catalog Number: 120092
Terminated
LJSK902135
Aug 6, 2005United States Surgical Corporation
ChemoSIte Cathteter Introducer Kit with 7 French Peel-Away Sheath Catalog Number: 120089
Terminated
LJSK902135
Aug 6, 2005United States Surgical Corporation
ChemoSite Implantable venous access sytem with printed silicone Catheter and 9 French Introducer Kit Catalog Number: 120066
Terminated
LJSK902135
Aug 6, 2005United States Surgical Corporation
ChemoSite Implantable venous access sytem with printed Polyurethane Catheter and 9 French Introducer Kit Catalog Number: 120045
Terminated
LJSK902135
Aug 6, 2005United States Surgical Corporation
ChemoSite Catheter Introducer Kit with 9 French Peel-Away Sheath Catalog Number: 120039
Terminated
LJSK902135
Aug 6, 2005United States Surgical Corporation
ChemoSite Low Profile, Implantable Low Profile Mini Catheter Venous Access System with 9 French Introducer Kit with Silicone Catheter Catalog Number: 120025
Terminated
LJSK902135
Aug 6, 2005United States Surgical Corporation
ChemoSite Low Profile, Implantable Low Profile Mini Catheter Venous Access System with printed Polyurethane Catheter and 9 French Introducer Kit Catalog Number: 120021
Terminated
LJSK902135
Aug 6, 2005United States Surgical Corporation
ChemoSite Low Profile, Implantable Low Profile Mini Catheter Venous Access System with printed Polyurethane Catheter and 7 French Introducer Kit Catalog Number: 120011
Terminated
LJSNone listed
Jul 28, 2005Boston Scientific Corporation
PICC Custom Kit GENESIS MEDICAL CENTER, 4.5F Dual Lumen , Catalog #60M120522. UPN M00160M1205221. Firm on label: Boston Scientific Corporation, NAMIC Technology Center, 10 Glens Falls Technical Par
Terminated
LJSK963097
Jul 28, 2005Boston Scientific Corporation
PASV PICC Catheter - 4.5 Fr Dual Lumen, Catalog #PIC402CKMS, Material Number M001PIC402CKMSO. Responsible firm on label: Boston Scientific *** Manufactured at: 10 Glens Falls Technical Park, Glens
Terminated
LJSK963097
Jul 28, 2005Boston Scientific Corporation
PASV PICC Catheter - 4.5 Fr Dual Lumen, Catalog #PIC402CKIR, Material Number M001PIC402CKIRO. Responsible firm on label: Boston Scientific *** Manufactured at: 10 Glens Falls Technical Park, Glens
Terminated
LJSK963097
Jul 28, 2005Boston Scientific Corporation
PASV PICC Catheter - 4.5 Fr Dual Lumen, Catalog #PIC402CK, Material Number M001PIC402CK0. Responsible firm on label: Boston Scientific *** Manufactured at: 10 Glens Falls Technical Park, Glens Fall
Terminated
LJSK963097
Jun 25, 2005Kendall Healthcare Products Co
Tyco Healthcare Kendall Argyle Neonatal Pediatric PICC, 1.9 Fr/Ch x 30 cm Dual Lumen PICC Catheter, REF 43304. A single catheter in a thermoformed tray with a Tyvek lid. The lidded tray is packaged o
Terminated
LJSK042461
Feb 18, 2005Arrow International Inc
Arrow PICC Two Lumen Peripherally Inserted Central Catheter Set with Blue FlexTip Catheter, Seldinger Technique with 130 cm Platinum Tipped Marked Wire. Catalog number PR-05052-LW
Terminated
LJSK930129
Feb 18, 2005Arrow International Inc
Arrow PICC Kit with Blue Flex Tip Catheter and Placement Wire. Catalog number PK-01552-WSSP
Terminated
LJSK930129
Jan 20, 2005Boston Scientific Corporation
PASV PICC, 3F, single lumen, CUSTOM KIT - VANDERBILT UNIVERSITY MEDICAL CENTER. Catalog #60M220991, UPN #M00160M2209910. Firm on label: Boston Scientific Corp, NAMIC Technology Center, 10 Glens Fal
Terminated
LJSK021704
Jan 20, 2005Boston Scientific Corporation
VAXCEL WITH PASV PICC, 3F, single lumen. CUSTOM KIT - UNIVERSITY OF NEW MEXICO HOSPITAL, Catalog # 60M210624, UPN #M00160M2106240. Firm on label: Boston Scientific Corp, NAMIC Technology Center, 1
Terminated
LJSK021704
Jan 20, 2005Boston Scientific Corporation
PASV PICC CUSTOM KIT, 3F, single lumen - CHILDREN''S HEALTHCARE OF ATLANTA, Catalog # 60M195071, UPN # M00160M1950710. Firm on label: Boston Scientific Corp, NAMIC Technology Center, 10 Glens Falls
Terminated
LJSK021704
Jan 20, 2005Boston Scientific Corporation
VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen: CUSTOM KIT - GENESIS MEDICAL CENTER EAST, Catalog #60M120521, UPN # M00160M1205210; Firm on label: Boston Scientific Corp, NAMI
Terminated
LJSK021704
Jan 20, 2005Boston Scientific Corporation
VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen, sold in kits, Catalog #45-454, UPN #M001454540; Firm on label: Boston Scientific, One Boston Scientific Place, Natick, MA . Man
Terminated
LJSK021704
Jan 20, 2005Boston Scientific Corporation
VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen, sold in a kit, Catalog #45-452; UPN #M001454520. Firm on label: Boston Scientific, One Boston Scientific Place, Natick, MA . Ma
Terminated
LJSK021704
Jan 20, 2005Boston Scientific Corporation
VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen, sold in a kit, Catalog #45-451, UPN #M001454510, Firm on label: Boston Scientific, One Boston Scientific Place, Natick, MA . M
Terminated
LJSK021704
Jan 20, 2005Boston Scientific Corporation
VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen. Catalog #45-450, UPN #M001454500; sold as individual catheters. Firm on label: Boston Scientific, One Boston Scientific Place,
Terminated
LJSK021704
Jan 8, 2005Arrow International Inc
NeoPICC 1.9 FR Catheter. Percutaneous Implanted long term intravascular catheter. The product is shipped in cases of 5 units. Catalog numbers S1PIC1.9-S, S1PIC1.9-N, S1PIC1.9-SMK, and S1PIC1.9-C.
Terminated
LJSK970434
Jul 22, 2004Braun,B Medical Inc
18G Catheter is a component in various kits.
Terminated
LJSK961745
K971085
Jul 20, 2004Becton Dickinson Infusion Therapy
BD L-Cath EX (28ga x 20cm), L-Cath Catheter System
Terminated
LJSK920755
Jul 20, 2004Becton Dickinson Infusion Therapy
BD L-Cath EX (20ga x 15cm), L-Cath Catheter System
Terminated
LJSK920755
Jul 20, 2004Becton Dickinson Infusion Therapy
BD L-Cath NN (24ga x 30cm), L-Cath Catheter System
Terminated
LJSK920755
May 15, 2003Becton Dickinson Infusion Therapy
BD First PICC 3F 65 cm Single Lumen Procedure Kit.
Terminated
LJSK945499

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