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) |
|---|---|---|---|
| Jun 1, 2017 | Arrow 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 |
LJS | K121941 |
| May 9, 2017 | Arrow 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 |
LJS | K061289 |
| May 9, 2017 | Arrow 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 |
LJS | K112896 |
| Mar 8, 2017 | Arrow International Inc The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein. Terminated |
LJS | K112896 |
| Jan 11, 2017 | Arrow 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 |
LJS | K930129 |
| Nov 28, 2016 | Angiodynamics 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 |
LJS | K150448 |
| Nov 28, 2016 | Angiodynamics 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 |
LJS | K150448 |
| Nov 28, 2016 | Angiodynamics 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 |
LJS | K150448 |
| Nov 28, 2016 | Angiodynamics 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 |
LJS | K150448 |
| Nov 28, 2016 | Angiodynamics 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 |
LJS | K150448 |
| Nov 28, 2016 | Angiodynamics 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 |
LJS | K150448 |
| Nov 28, 2016 | Angiodynamics 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 |
LJS | K150448 |
| Nov 28, 2016 | Angiodynamics 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 |
LJS | K150448 |
| Nov 28, 2016 | Angiodynamics 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 |
LJS | K150448 |
| Nov 28, 2016 | Angiodynamics 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 |
LJS | K091261 |
| Nov 28, 2016 | Angiodynamics 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 |
LJS | K091261 |
| Nov 28, 2016 | Angiodynamics 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 |
LJS | K091261 |
| Nov 28, 2016 | Angiodynamics 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 |
LJS | K091261 |
| Aug 29, 2016 | Angiodynamics 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 |
LJS | K142616 |
| Aug 29, 2016 | Angiodynamics 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 |
LJS | K142616 |
| Aug 29, 2016 | Angiodynamics 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 |
LJS | K142616 |
| Jun 8, 2016 | Angiodynamics 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 |
LJS | K142616 |
| Jun 8, 2016 | Angiodynamics 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 |
LJS | K142616 |
| Mar 14, 2016 | Navilyst 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 |
LJS | K021704 |
| Mar 14, 2016 | Navilyst 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 |
LJS | K021704 |
| Mar 14, 2016 | Navilyst 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 |
LJS | K021704 |
| Mar 14, 2016 | Navilyst 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 |
LJS | K021704 |
| Mar 14, 2016 | Navilyst 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 |
LJS | K021704 |
| Mar 14, 2016 | Navilyst 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 |
LJS | K021704 |
| Mar 14, 2016 | Navilyst 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 |
LJS | K021704 |
| Mar 14, 2016 | Navilyst 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 |
LJS | K021704 |
| Mar 14, 2016 | Navilyst 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 |
LJS | K021704 |
| Mar 14, 2016 | Navilyst 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 |
LJS | K021704 |
| Mar 14, 2016 | Navilyst 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 |
LJS | K021704 |
| Mar 14, 2016 | Navilyst 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 |
LJS | K021704 |
| Mar 14, 2016 | Navilyst 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 |
LJS | K021704 |
| Mar 14, 2016 | Navilyst 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 |
LJS | K021704 |
| Mar 14, 2016 | Navilyst 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 |
LJS | K021704 |
| Mar 14, 2016 | Navilyst 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 |
LJS | K021704 |
| Mar 14, 2016 | Navilyst 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 |
LJS | K021704 |
| Mar 14, 2016 | Navilyst 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 |
LJS | K021704 |
| Mar 14, 2016 | Navilyst 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 |
LJS | K021704 |
| Mar 14, 2016 | Navilyst 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 |
LJS | K021704 |
| Mar 14, 2016 | Navilyst 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 |
LJS | K021704 |
| Mar 14, 2016 | Navilyst 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 |
LJS | K021704 |
| Mar 14, 2016 | Navilyst 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 |
LJS | K021704 |
| Feb 17, 2016 | Arrow 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 |
LJS | K061289 |
| Feb 17, 2016 | Arrow International Inc Catheter, Percutaneous
The Arrow Single-Lumen Catheter permits venous access to the central circulation. Terminated |
LJS | K061289 |
| Feb 17, 2016 | Arrow International Inc Cather, Ultrasound, Intravascular
The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. Terminated |
LJS | K061289 |
| Feb 17, 2016 | Arrow International Inc Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days.
An access kit only, contains no base components Terminated |
LJS | K061289 |
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