# K100892: Renegade HI-Flo Fathom Kit Model M001182XXX

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Apr 12, 2010 after 12 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: 1 generation back to K000177 (2000). 1 ancestor in all.
7 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K132947: Direxion and Direxion HI-Flo Torqueable Microcatheters (2013), 5 descendants of its own
- K142259: Direxion Torqueable Microcatheter (2014), 4 descendants of its own
- K163701: Direxion and Direxion HI-FLO Torqueable Microcatheters (2017), 3 descendants of its own
- K201792: TRUSELECT Microcatheter (2020), 1 descendant of its own
- K260771: TruSelect™ 2.6 Microcatheter (2026), 0 descendants of its own

## Indications for use
The Renegade Hi-Flo Fathom Kit 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.

Source page: https://510kreport.com/device/K100892
Methodology: https://510kreport.com/methodology