The following data is part of a premarket notification filed by Horizon Medical Products, Inc. with the FDA for Triumph Vtx With Lifevalve Catheter.
| Device ID | K032557 |
| 510k Number | K032557 |
| Device Name: | TRIUMPH VTX WITH LIFEVALVE CATHETER |
| 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 | 2003-08-19 |
| Decision Date | 2003-09-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H787SSAX16I0 | K032557 | 000 |
| H787SSAX14I0 | K032557 | 000 |
| H787SPDX16I0 | K032557 | 000 |
| H787SPDX14I0 | K032557 | 000 |
| H787SPAX16I0 | K032557 | 000 |
| H787PSDX10I0 | K032557 | 000 |
| H787PSAX10I0 | K032557 | 000 |