510(k) K131038 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
NMI PICC MAXIMAL BARRIER NURSING KITS
| Applicant | Navilyst Medical, Inc., Marlborough MA, US |
| Decision | Substantially Equivalent, May 9, 2013 |
| Received | Apr 15, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K131038
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.