# K140329: Renegade HI-Flo Microcatheter, Microcatheter Kit, Fathom System, Fathom Kit

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific
- Decided: May 15, 2014 after 94 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K000177 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100892: Renegade HI-Flo Fathom Kit Model M001182XXX, Boston Scientific Corp (2010) Summary page 1.
- K000177: Renegade HI-Flo Microcatheter, Boston Scientific Corp (2000) Summary page 1.

## Indications for use
The Renegade HI-FLO FATHOM Kit / System is intended for peripheral vascular use. The FATHOM guidewire can be used to selectively introduce and position the Renegade HI-FLO microcatheter in the peripheral vasculature. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels. The Renegade HI-FLO Microcatheter is intended for peripheral vascular use. The microcatheter can be coaxially tracked over a steerable guidewire in order to access distal, tortuous vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels. Diagnostic, embolic, or therapeutic agents to be used in accordance with specifications outlined by the manufacturer.

Source page: https://510kreport.com/device/K140329
Methodology: https://510kreport.com/methodology