The following data is part of a premarket notification filed by Smiths Medical Md, Inc. with the FDA for Port-a-cath, Port-a-cath Ii, Proport And P.a.s. Port Implantable Venous Access Systems With Dual Layer Catheter.
| Device ID | K060036 |
| 510k Number | K060036 |
| Device Name: | PORT-A-CATH, PORT-A-CATH II, PROPORT AND P.A.S. PORT IMPLANTABLE VENOUS ACCESS SYSTEMS WITH DUAL LAYER CATHETER |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Contact | Melanie Hess |
| Correspondent | Melanie Hess SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-05 |
| Decision Date | 2006-05-17 |
| Summary: | summary |