# 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

- Pathway: 510(k) (Traditional)
- Applicant: Stryker
- Decided: Mar 13, 2019 after 89 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: 7 generations back to K003880 (2001). 12 ancestors in all.
14 later devices descend from it; 3 cite it directly.
0 of 27 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 5.
- K180715: React 68 Catheter, Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (2018) Summary page 5.

## Most influential descendants
- 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
- K241244: CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter (2024), 1 descendant of its own

## Indications for use
The AXS Catalyst Distal Access Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The AXS Catalyst Distal Access Catheter is also indicated for use as a conduit for retrieval devices.

Source page: https://510kreport.com/device/K183463
Methodology: https://510kreport.com/methodology