510(k) K032008 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
VAXCEL WITH PASV PORT, MODEL 45-213
| Applicant | Boston Scientific Corp, Natick, MA, US |
| Decision | Substantially Equivalent, Jul 14, 2003 |
| Received | Jun 30, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K032008
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 1, 2010 | Navilyst Medical, Inc Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Mini-Port with PASV Valve and 6F Polyurethane Catheter (1.1 mm/1.9 mm), REF Catalog No. 45-213, UPN Product No. M001452130, STERILE, Rx O Terminated |
LJT | None listed |
| Jul 1, 2010 | Navilyst Medical, Inc Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Mini-Port With PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm), REF Catalog No. 45-215, UPN Product No. M001452150, STERILE, Rx O Terminated |
LJT | None listed |
| Jul 1, 2010 | Navilyst Medical, Inc Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Mini-Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm), REF Catalog No. 45-220, UPN Product No. M001452200, STERILE, Rx ONLY, Terminated |
LJT | None listed |
| Jul 1, 2010 | Navilyst Medical, Inc Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Standard Port with PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm), REF Catalog No. 45-362, UPN Product No. M001453620, STERILE Terminated |
LJT | None listed |
| Jul 1, 2010 | Navilyst Medical, Inc Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Standard Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm), REF Catalog No. 45-364, UPN Product No. M001453640, STERILE, Rx O Terminated |
LJT | None listed |
| Jul 1, 2010 | Navilyst Medical, Inc Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Plastic Standard Port with PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm), REF Catalog No. 45-366, UPN Product No. M0 01453660, Sterile, Terminated |
LJT | None listed |
| Jul 1, 2010 | Navilyst Medical, Inc Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM), Plastic Standard Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm), REF Catalog No. 45-368, UPN Product No. M001453680, STERILE, Rx O Terminated |
LJT | None listed |
| Sep 2, 2005 | Boston Scientific Corporation Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV Mini/T/PU/6/1.1/1.9/63
Catalog Number : 45-213 Terminated |
KOB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.