# K132947: Direxion and Direxion HI-Flo Torqueable Microcatheters

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Oct 18, 2013 after 29 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.
5 later devices descend from it; 1 cites it directly.
0 of 8 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.

## Most influential descendants
- 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
- K231821: XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,) (2023), 0 descendants of its own

## Indications for use
The Direxion and Direxion HI-FLO Torqueable Microcatheters are intended for peripheral vascular use. The pre-loaded Fathom and Transend Guidewires can be used to selectively introduce and position the microcatheter in the peripheral vasculature. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.

Source page: https://510kreport.com/device/K132947
Methodology: https://510kreport.com/methodology