Panels › General Hospital › Product code LLD · Class 2
Port & Catheter, Implanted, Subcutaneous, Intraperitoneal
Regulation 880.5965
0510(k)s in 12 months (4 all time)
0recalls in 12 months (6 all time)
6recalls that name a 510(k)
Top companies in LLD
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific Corporation | 0 | 6 |
| Pharmacia, Inc. | 2 | 0 |
| Burron Medical Products, Inc. | 1 | 0 |
| Pharmacia Deltec, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | K032375 K032600 |
| 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 | K032375 K032600 |
| 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 | K032375 K032600 |
| 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 | K031844 |
| 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 | K031844 |
| Apr 28, 2005 | Boston Scientific Corporation Vaxcel Low Profile Port with PASV Valve and 6F Polyurethane Catheter. CATALOG NO. 45-233. Ref. # M001452330. FIRM ON LABEL: Boston Scientific MEDI-TECH. Manufactured for: Boston Scientific C Terminated |
LLD | K032600 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.