The following data is part of a premarket notification filed by Horizon Medical Products, Inc. with the FDA for Lifeport Vtx Access System,model Vtx 7000 Series.
| Device ID | K010767 |
| 510k Number | K010767 |
| Device Name: | LIFEPORT VTX ACCESS SYSTEM,MODEL VTX 7000 SERIES |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | HORIZON MEDICAL PRODUCTS, INC. 1 HORIZON WAY Manchester, GA 31816 |
| Contact | Penny M Northcutt |
| Correspondent | Penny M Northcutt 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 | 2001-03-14 |
| Decision Date | 2001-04-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H787LVTX70150 | K010767 | 000 |
| H787LVTX55130 | K010767 | 000 |
| H787LVTX55550 | K010767 | 000 |
| H787LVTX55570 | K010767 | 000 |
| H787LVTX75130 | K010767 | 000 |
| H787LVTX50130 | K010767 | 000 |
| H787LVTX50150 | K010767 | 000 |
| H787LVTX52130 | K010767 | 000 |
| H787LVTX70130 | K010767 | 000 |
| H787LVTX50570 | K010767 | 000 |