The following data is part of a premarket notification filed by Horizon Medical Products, Inc. with the FDA for Vortex Access System.
| Device ID | K010189 |
| 510k Number | K010189 |
| Device Name: | VORTEX ACCESS SYSTEM |
| 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 | 2001-01-22 |
| Decision Date | 2001-02-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H787P5455K0 | K010189 | 000 |
| H787P5405K0 | K010189 | 000 |
| H787P5355K0 | K010189 | 000 |
| H787P5305K0 | K010189 | 000 |
| H787P12355K0 | K010189 | 000 |
| H787P12305K0 | K010189 | 000 |
| H787P12155K0 | K010189 | 000 |
| H787P12105K0 | K010189 | 000 |