510(k) K963097 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
CLAMPLESS VALVED CATHETER-PICC (CVC-PICC)
| Applicant | Bmw Medical, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Oct 18, 1996 |
| Received | Aug 9, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963097
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 28, 2005 | Boston Scientific Corporation PASV PICC Catheter - 4.5 Fr Dual Lumen, Catalog #PIC402CK, Material Number M001PIC402CK0. Responsible firm on label: Boston Scientific *** Manufactured at: 10 Glens Falls Technical Park, Glens Fall Terminated |
LJS | None listed |
| Jul 28, 2005 | Boston Scientific Corporation PASV PICC Catheter - 4.5 Fr Dual Lumen, Catalog #PIC402CKIR, Material Number M001PIC402CKIRO. Responsible firm on label: Boston Scientific *** Manufactured at: 10 Glens Falls Technical Park, Glens Terminated |
LJS | None listed |
| Jul 28, 2005 | Boston Scientific Corporation PASV PICC Catheter - 4.5 Fr Dual Lumen, Catalog #PIC402CKMS, Material Number M001PIC402CKMSO. Responsible firm on label: Boston Scientific *** Manufactured at: 10 Glens Falls Technical Park, Glens Terminated |
LJS | None listed |
| Jul 28, 2005 | Boston Scientific Corporation PICC Custom Kit GENESIS MEDICAL CENTER, 4.5F Dual Lumen , Catalog #60M120522. UPN M00160M1205221. Firm on label: Boston Scientific Corporation, NAMIC Technology Center, 10 Glens Falls Technical Par Terminated |
LJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.