The following data is part of a premarket notification filed by Horizon Medical Products, Inc. with the FDA for Modification To Vortex Mp Vascular Access Port.
| Device ID | K033473 |
| 510k Number | K033473 |
| Device Name: | MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | HORIZON MEDICAL PRODUCTS, INC. 1 HORIZON WAY Manchester, GA 31816 |
| Contact | Scott Moeller |
| Correspondent | Scott Moeller HORIZON MEDICAL PRODUCTS, 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 | 2003-11-03 |
| Decision Date | 2003-11-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H787MPP5SDT0 | K033473 | 000 |
| H787MPP5SAT0 | K033473 | 000 |
| H787MPP5PT0 | K033473 | 000 |
| H787MPP5PK0 | K033473 | 000 |