510(k) K031844 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
VAXCEL WITH PASV PORT (LOW PROFILE), MODELS 45-236 AND 45-238
| Applicant | Boston Scientific Corp, Glens Falls NY, US |
| Decision | Substantially Equivalent, Jul 15, 2003 |
| Received | Jun 16, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031844
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 28, 2005 | Boston Scientific Corporation Vaxcel Low Profile Port with PASV valve and 8F Silicone Catheter. CATALOG NO. 45-236, Ref. # M001452360. FIRM ON LABEL: Boston Scientific MEDI-TECH. Manufactured for: Boston Scientific Corp., One Terminated |
LLD | None listed |
| Apr 28, 2005 | Boston Scientific Corporation Vaxcel Low Profile Port with PASV valve and 8F Polyurethane Catheter. CATALOG NO. 45-238, Ref. # M001452380. FIRM ON LABEL: Boston Scientific MEDI-TECH. Manufactured for: Boston Scientific Corp., Terminated |
LLD | None listed |
| Jul 20, 2004 | Boston Scientific Corporation Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, Low Profile PS port, Implantable Port System, Model # M001452380, Catalog #45-238 Terminated |
LJT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.