The following data is part of a premarket notification filed by Horizon Medical Products, Inc. with the FDA for Triumph-1 Port.
| Device ID | K951814 |
| 510k Number | K951814 |
| Device Name: | TRIUMPH-1 PORT |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | HORIZON MEDICAL PRODUCTS, INC. 4200 NORTHSIDE PARKWAY N.W. Atlanta, GA 30327 |
| Contact | Roddy J. H Clark |
| Correspondent | Roddy J. H Clark HORIZON MEDICAL PRODUCTS, INC. 4200 NORTHSIDE PARKWAY N.W. Atlanta, GA 30327 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-18 |
| Decision Date | 1995-08-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H787SSDX16I0 | K951814 | 000 |
| H787SSDX14I0 | K951814 | 000 |
| H787SSDX10I0 | K951814 | 000 |