# K180715: React 68 Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Decided: Jul 4, 2018 after 107 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K003880 (2001). 11 ancestors in all.
19 later devices descend from it; 3 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151667: AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm, Stryker (2015) Summary page 4.
- K110055: Reverse Medical Reflex Guide Catheter, Reverse Medical Corporation (2011) Summary page 4.

## Most influential descendants
- K183463: AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm (2019), 14 descendants of its own
- K190833: AXS Vecta Aspiration Catheter (2019), 6 descendants of its own
- K191237: CERENOVUS Large Bore Catheter (2019), 5 descendants of its own
- K202752: AXS Vecta 46 Intermediate Catheter (2021), 3 descendants of its own
- K193380: CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set (2020), 3 descendants of its own

## Indications for use
The React™ 68 Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

Source page: https://510kreport.com/device/K180715
Methodology: https://510kreport.com/methodology