# K050542: Marian Infant Feeding Tube (Guardianpicc Percutaneous Central Venous Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Marian Medical, Inc.
- Decided: Jul 26, 2005 after 146 days
- Product code: LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5970
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The GuardianPICCTM is a sterile, disposable, single lumen catheter intended for I.V. administration. The catheter may be used for delivery of TPN nutritional solutions, antibiotics, pain medications, chemotherapy and hydration. The catheter is inserted peripherally and provides a mechanism for the administration of IV medications to the large central veins of the body.

Source page: https://510kreport.com/device/K050542
Methodology: https://510kreport.com/methodology