The following data is part of a premarket notification filed by Smiths Medical Md, Inc. with the FDA for Port-a-cath Ii Regional Arterial Portal System.
| Device ID | K033686 |
| 510k Number | K033686 |
| Device Name: | PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | SMITHS MEDICAL MD, INC. 1265 GREY FOX ROAD St. Paul, MN 55112 |
| Contact | Patricia A Laforte |
| Correspondent | Patricia A Laforte SMITHS MEDICAL MD, INC. 1265 GREY FOX ROAD 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 | 2003-11-24 |
| Decision Date | 2004-01-23 |
| Summary: | summary |