The following data is part of a premarket notification filed by Marian Medical, Inc. with the FDA for Marian Infant Feeding Tube (guardianpicc Percutaneous Central Venous Catheter.
| Device ID | K050542 |
| 510k Number | K050542 |
| Device Name: | MARIAN INFANT FEEDING TUBE (GUARDIANPICC PERCUTANEOUS CENTRAL VENOUS CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | MARIAN MEDICAL, INC. 319 WESTPORT DR. Louisville, KY 40207 |
| Contact | Sandra Winkler |
| Correspondent | Sandra Winkler MARIAN MEDICAL, INC. 319 WESTPORT DR. Louisville, KY 40207 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-02 |
| Decision Date | 2005-07-26 |