# K123605: Smartflow Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Mri Interventions, Inc.
- Decided: Aug 16, 2013 after 268 days
- Product code: HCA (Catheter, Ventricular)
- Device class: 2
- Regulation: 21 CFR 882.4100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K102101 (2011). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102101: Surgivision MR Compatible Ventricular Cannula, Surgivision, Inc. (2011) Summary page 1.

## Most influential descendants
- K161731: Cleveland Multiport Ventricular Catheter Set (2017), 0 descendants of its own

## Indications for use
The SmartFlowTm Flex Ventricular Catheter is intended for injection of Cytarabine or removal of CSF from the ventricles during intracranial procedures. The device is not intended for implant. This device is intended for "single patient use only."

Source page: https://510kreport.com/device/K123605
Methodology: https://510kreport.com/methodology