510(k) K032375 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
VAXCEL PORT, MODELS 45-336 AND 45-338
| Applicant | Boston Scientific Corp, Glens Falls NY, US |
| Decision | Substantially Equivalent, Aug 19, 2003 |
| Received | Aug 1, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K032375
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 30, 2005 | Boston Scientific Corporation Vaxcel Plastic Low Profile Port (non-valved) chest port, with 6Fr Polyurethane Catheter, Catalog 45-333, Material #M001453330. Firm on label: Boston Scientific *** Manufactured at: 10 Glens Fal Terminated |
LLD | None listed |
| Jun 30, 2005 | Boston Scientific Corporation Vaxcel Plastic Low Profile (non-valved) chest port, with 8Fr Silicone Catheter, Catalog #45-336, Material #M001453360. Firm on label: Boston Scientific *** Manufactured at: 10 Glens Falls Technical Terminated |
LLD | None listed |
| Jun 30, 2005 | Boston Scientific Corporation Vaxcel Plastic Low Profile (non-valved) chest port, with 8Fr Polyurethane Catheter, Catalog # 45-338, Material #M001453380. Firm on label: Boston Scientific *** Manufactured at: 10 Glens Falls Tec Terminated |
LLD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.