510(k) K091261 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
NMI PICC
| Applicant | Navilyst Medical, Inc., Marlborough MA, US |
| Decision | Substantially Equivalent, May 12, 2009 |
| Received | Apr 29, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091261
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE PG), Cat no. 55-711 Terminated |
LJS | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.