510(k) K021704 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
VAXCEL PICC WITH PASV VALVE TECHNOLOGY
| Applicant | Catheter Innovations, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Jun 6, 2002 |
| Received | May 23, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K021704
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| Jan 20, 2005 | Boston 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 |
LJS | None listed |
| Jan 20, 2005 | Boston 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 |
LJS | None listed |
| Jan 20, 2005 | Boston 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 |
LJS | None listed |
| Jan 20, 2005 | Boston 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 |
LJS | None listed |
| Jan 20, 2005 | Boston 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 |
LJS | None listed |
| Jan 20, 2005 | Boston 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 |
LJS | None listed |
| Jan 20, 2005 | Boston 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 |
LJS | None listed |
| Jan 20, 2005 | Boston 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 |
LJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.