The following data is part of a premarket notification filed by Horizon Medical Products, Inc. with the FDA for Horizon Medical Products Microport 2 Peripheral Access Port System.
| Device ID | K994196 |
| 510k Number | K994196 |
| Device Name: | HORIZON MEDICAL PRODUCTS MICROPORT 2 PERIPHERAL ACCESS PORT SYSTEM |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | HORIZON MEDICAL PRODUCTS, INC. 1 HORIZON WAY Manchester, GA 31816 |
| Contact | John Tartal |
| Correspondent | John Tartal HORIZON MEDICAL PRODUCTS, INC. 1 HORIZON WAY Manchester, GA 31816 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-13 |
| Decision Date | 2000-02-10 |
| Summary: | summary |