The following data is part of a premarket notification filed by Rita Medical Systems, Inc. with the FDA for Vortex Ez Vascular Access Port.
| Device ID | K050176 |
| 510k Number | K050176 |
| Device Name: | VORTEX EZ VASCULAR ACCESS PORT |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | RITA MEDICAL SYSTEMS, INC. 1 HORIZON WAY Manchester, GA 31816 |
| Contact | Mary Gossard |
| Correspondent | Mary Gossard RITA MEDICAL SYSTEMS, INC. 1 HORIZON WAY Manchester, GA 31816 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-26 |
| Decision Date | 2005-02-25 |
| Summary: | summary |