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)
Jun 1, 2017Arrow International Inc
ARROW PICC powered by ARROW VPS Stylet The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion
Terminated
LJSK121941
May 9, 2017Arrow International Inc
Arrow Pressure Injectable PICC Kit Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access t
Terminated
LJSK061289
May 9, 2017Arrow International Inc
1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long
Terminated
LJSK112896
Mar 8, 2017Arrow International Inc
The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein.
Terminated
LJSK112896
Jan 11, 2017Arrow International Inc
Vascular catheter introduction kit The PICC is indicated for short or long term peripheral access to the central Venous system for intravenous therapy, blood sampling, infusion and power injection of
Terminated
LJSK930129
Nov 28, 2016Angiodynamics Inc. (Navilyst Medical Inc.)
Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technolog
Terminated
LJSK150448
Nov 28, 2016Angiodynamics Inc. (Navilyst Medical Inc.)
Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technolog
Terminated
LJSK150448
Nov 28, 2016Angiodynamics Inc. (Navilyst Medical Inc.)
Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technolog
Terminated
LJSK150448
Nov 28, 2016Angiodynamics Inc. (Navilyst Medical Inc.)
Bio-Stable 5F DL-55CM IR-145 Kit Valved with Nit GW, UPN H965458890, Catalog No. 45-889 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology
Terminated
LJSK150448
Nov 28, 2016Angiodynamics Inc. (Navilyst Medical Inc.)
Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458830, Catalog No. 45-883 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are i
Terminated
LJSK150448
Nov 28, 2016Angiodynamics Inc. (Navilyst Medical Inc.)
Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458710, Catalog No. 45-871 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are i
Terminated
LJSK150448
Nov 28, 2016Angiodynamics Inc. (Navilyst Medical Inc.)
Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458710, Catalog No. 45-871 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are i
Terminated
LJSK150448
Nov 28, 2016Angiodynamics Inc. (Navilyst Medical Inc.)
Bio-Stable 5F DL-55CM IR-145 Kit Valved PG, UPN H965458330, Catalog No. 45-833 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indi
Terminated
LJSK150448
Nov 28, 2016Angiodynamics Inc. (Navilyst Medical Inc.)
Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, UPN H965458180, Catalog No. 45-818 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indi
Terminated
LJSK150448
Nov 28, 2016Angiodynamics Inc. (Navilyst Medical Inc.)
XCELA PASV 5F DL 55CM IR-145 KIT PG, UPN H965457330, Catalog No. 45-733 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated fo
Terminated
LJSK091261
Nov 28, 2016Angiodynamics Inc. (Navilyst Medical Inc.)
XCELA PASV 5F DL 55CM MST-70 KIT PG, UPN H965457320, Catalog No. 45-732 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated fo
Terminated
LJSK091261
Nov 28, 2016Angiodynamics Inc. (Navilyst Medical Inc.)
XCELA PASV 5F DL 55CM IR-145 Nitinol Wire KIT PG, UPN H965251260, Catalog No. 25-126 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are
Terminated
LJSK091261
Nov 28, 2016Angiodynamics Inc. (Navilyst Medical Inc.)
Xcela PICC Kit with ENDEXO and PASV Valve Technology, XCELA PASV 5F DL 55CM MST-70 Nitinol KIT PG, UPN H965251250, Catalog No. 25-125 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioF
Terminated
LJSK091261
Aug 29, 2016Angiodynamics Inc. (Navilyst Medical Inc.)
BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit - UPN # H965750191/Catalog No:75-019 The BioFlo PICCs with ENDEXO and PASV Valve Technology are indicated for short or lon
Terminated
LJSK142616
Aug 29, 2016Angiodynamics Inc. (Navilyst Medical Inc.)
BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit - 1) UPN # H965750121/Catalog No: 5018265, 2) UPN # H965750131/Catalog No:5024787, 3) UPN # H965750141/Catalog No: 5024787, 4) UPN # H96
Terminated
LJSK142616
Aug 29, 2016Angiodynamics Inc. (Navilyst Medical Inc.)
Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The Xcela Power Injectable PICC is i
Terminated
LJSK142616
Jun 8, 2016Angiodynamics Inc. (Navilyst Medical Inc.)
Peripherally Inserted Central Catheters (PICC), UPN H965750191, Catalog # 75-019 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFl
Terminated
LJSK142616
Jun 8, 2016Angiodynamics Inc. (Navilyst Medical Inc.)
Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-014 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo
Terminated
LJSK142616
Mar 14, 2016Navilyst Medical, Inc., an AngioDyamics Company
BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965458970, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PI
Terminated
LJSK021704
Mar 14, 2016Navilyst Medical, Inc., an AngioDyamics Company
BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458980, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PI
Terminated
LJSK021704
Mar 14, 2016Navilyst Medical, Inc., an AngioDyamics Company
BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, Catheter Kit, UPN H965459410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with
Terminated
LJSK021704
Mar 14, 2016Navilyst Medical, Inc., an AngioDyamics Company
BioFlo PICC with ENDEXO and PASV Valve Technology, Maximal Barrier Nursing Kit, UPN H965750211 The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with
Terminated
LJSK021704
Mar 14, 2016Navilyst Medical, Inc., an AngioDyamics Company
BioFlo PICC with ENDEXO and PASV Valve Technology, MST-45 Kit, 6F-55cm, UPN H965458440 , Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC wit
Terminated
LJSK021704
Mar 14, 2016Navilyst Medical, Inc., an AngioDyamics Company
BioFlo PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965458420 & UPN H965458930, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo
Terminated
LJSK021704
Mar 14, 2016Navilyst Medical, Inc., an AngioDyamics Company
BioFlo PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458430 & UPN H965458840, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo
Terminated
LJSK021704
Mar 14, 2016Navilyst Medical, Inc., an AngioDyamics Company
BioFlo PICC with ENDEXO and PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965458410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC wi
Terminated
LJSK021704
Mar 14, 2016Navilyst Medical, Inc., an AngioDyamics Company
Xcela Hybrid PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN H965952440 & UPN H965952450, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV an
Terminated
LJSK021704
Mar 14, 2016Navilyst Medical, Inc., an AngioDyamics Company
Xcela Hybrid PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965952420 & UPN H965952460, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybr
Terminated
LJSK021704
Mar 14, 2016Navilyst Medical, Inc., an AngioDyamics Company
Xcela Hybrid PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965952430 & H965952470, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid P
Terminated
LJSK021704
Mar 14, 2016Navilyst Medical, Inc., an AngioDyamics Company
Xcela Hybrid PICC with PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965952410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PA
Terminated
LJSK021704
Mar 14, 2016Navilyst Medical, Inc., an AngioDyamics Company
Xcela PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN H965457440 Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC wit
Terminated
LJSK021704
Mar 14, 2016Navilyst Medical, Inc., an AngioDyamics Company
Xcela PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965251290 & H965457420, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC wit
Terminated
LJSK021704
Mar 14, 2016Navilyst Medical, Inc., an AngioDyamics Company
Xcela PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965457430, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are in
Terminated
LJSK021704
Mar 14, 2016Navilyst Medical, Inc., an AngioDyamics Company
Xcela PICC with PASV Valve Technology Catheter Kit, 6F-55cm, UPN H965457410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are i
Terminated
LJSK021704
Mar 14, 2016Navilyst Medical, Inc., an AngioDyamics Company
Vaxcel PICC with PASV Intermediate Safety MST Kit under the following labels: 1) 3F, UPN H965454370, 2) 4F UPN M001455940 & 3) 5F UPN M001455980 The Vaxcel PICC with PASV is indicated for use in estab
Terminated
LJSK021704
Mar 14, 2016Navilyst Medical, Inc., an AngioDyamics Company
Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001455910, Rx ONLY The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous s
Terminated
LJSK021704
Mar 14, 2016Navilyst Medical, Inc., an AngioDyamics Company
Vaxcel PICC with PASV MST-60 Kit under the following labels: 1) 3F, UPN H965454360, Rx ONLY, 2) 4F, UPN M001454590, Rx ONLY, 3) 5F, UPN's M001454640, M001454740 & M001454790, Rx ONLY The Vaxcel PICC w
Terminated
LJSK021704
Mar 14, 2016Navilyst Medical, Inc., an AngioDyamics Company
Vaxcel PICC with PASV MST-30 Kit under the following labels: 1) 4F, UPN M001454570, Rx ONLY, 2) 5F, UPN M001454620 & UPN M001454720, Rx ONLY & 3) 6F, UPN M001454770, Rx ONLY. The Vaxcel PICC with PASV
Terminated
LJSK021704
Mar 14, 2016Navilyst Medical, Inc., an AngioDyamics Company
Vaxcel PICC with PASV IR-145 Kit under the following labels: 1) 4F, UPN M001454580, Rx ONLY, 2) 5F, UPN M001454630, Rx ONLY & 3) 6F, UPN M001454780, Rx ONLY The Vaxcel PICC with PASV is indicated for
Terminated
LJSK021704
Mar 14, 2016Navilyst Medical, Inc., an AngioDyamics Company
Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001454560, Rx ONLY & 2) 5F, UPN M001454610, Rx ONLY. The Vaxcel PICC with PASV is indicated for use in establishing periphe
Terminated
LJSK021704
Mar 14, 2016Navilyst Medical, Inc., an AngioDyamics Company
Vaxcel PICC with PASV Catheter Kit under the following labels: 1) 3F, UPN H965454350, Rx ONLY, 2) 4F, UPN M001454550, Rx ONLY & 3) 5F, UPN M001454700, Rx ONLY. The Vaxcel PICC with PASV is indicated f
Terminated
LJSK021704
Feb 17, 2016Arrow International Inc
Catheter, Intravascular, Therapeutic, Short-Term Less than 30 days The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring
Terminated
LJSK061289
Feb 17, 2016Arrow International Inc
Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulation.
Terminated
LJSK061289
Feb 17, 2016Arrow International Inc
Cather, Ultrasound, Intravascular The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.
Terminated
LJSK061289
Feb 17, 2016Arrow International Inc
Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An access kit only, contains no base components
Terminated
LJSK061289

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