# K063795: Guardiancatheter-Urinary Drainage Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Marian Medical, Inc.
- Decided: Mar 5, 2007 after 73 days
- Product code: GBM (Catheter, Urethral)
- Device class: 2
- Regulation: 21 CFR 876.5130
- 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. The FDA summary names no predicate by number.

## Indications for use
The GuardianCatheter-Infant Urinary Drainage Catheter is a single lumen silicone urinary catheter Intended to drain urine In the neonatal patient population. This catheter is NOT a Foley (balloon) type catheter.

Source page: https://510kreport.com/device/K063795
Methodology: https://510kreport.com/methodology