510(k) K991897 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
CATHETER INNOVATIONS IMPLANTABLE PORT
| Applicant | Catheter Innovations, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Oct 21, 1999 |
| Received | Jun 4, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991897
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 6, 2006 | Boston Scientific Corporation Implantable Chest Ports labeled: Titanium Single Lumen Port with PASV valve and 6.6F Silicone Catheter. Boston Scientific Cat. # PRTA66P M001PRTA66P0. Firm on label: Boston Scientific Natick, MA a Terminated |
LJS | None listed |
| Jan 6, 2006 | Boston Scientific Corporation Implantable Chest Ports labeled: Titanium Single Lumen Port with PASV Valve and 6.6F Silicone Catheter. Boston Scientific Cat. # PRTA66A M001PRTA66AO. Firm on label: Boston Scientific, Natick, Terminated |
LJS | None listed |
| Sep 2, 2005 | Boston Scientific Corporation Implantable Chest Ports With PASV Valve Technology - Single Lumen - PASV Port/6.6/SL/T/A
Catalog Number: PRTA66A Terminated |
KOB | None listed |
| Sep 2, 2005 | Boston Scientific Corporation Implantable Chest Ports With PASV Valve Technology -Single Lumen - PASV Port/6.6/SL/T/PA
Catalog Number: PRTA66P Terminated |
KOB | None listed |
| Sep 2, 2005 | Boston Scientific Corporation Implantable Chest Ports With PASV Valve Technology - Single Lumen - PASV Port/9.6/SL/T/A
Catalog Number: M001PRTA96A0 Terminated |
KOB | None listed |
| Sep 2, 2005 | Boston Scientific Corporation Implantable Chest Ports With PASV Valve Technology - Single Lumen - PASV Port/9.6/SL/T/PA
Catalog Number: PRTA96P Terminated |
KOB | None listed |
| Sep 2, 2005 | Boston Scientific Corporation Implantable Chest Ports With PASV Valve Technology - Dual Lumen - PASV Port/10/DL/T/A
Catalog Number: PRTB10A Terminated |
KOB | None listed |
| Sep 2, 2005 | Boston Scientific Corporation Implantable Chest Ports With PASV Valve Technology - Dual Lumen - PASV Port/10/DL/T/PA
Catalog Number: PRTB10P Terminated |
KOB | None listed |
| Jul 20, 2004 | Boston Scientific Corporation Titanium Dual Lumen Implantable Port with PASV Valve and 10F Silicone Catheter. Catalog No/REF: PRTB10A, Model No. M001PRTB10A. Firm on label: Boston Scientific Corp., NAMIC Technology Center, Glen Terminated |
None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.