# K151667: AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm

- Pathway: 510(k) (Traditional)
- Applicant: Stryker
- Decided: Nov 13, 2015 after 147 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K003880 (2001). 9 ancestors in all.
26 later devices descend from it; 5 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133177: Modified HD Guide Catheter, Concentric Medical, Inc. (2014) Summary page 4.
- K110483: Modified HD Guide Catheter, Concentric Medical, Inc. (2011) Summary page 4.
- K090335: HD Guide Catheter, Concentric Medical, Inc. (2009) Summary page 4.

## Most influential descendants
- K180715: React 68 Catheter (2018), 19 descendants of its own
- 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
- K234115: APRO 55 Catheter (2024), 4 descendants of its own

## Recalls of this device
- Nov 3, 2017 · Class II · Z-0275-2018: Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical c
- Nov 3, 2017 · Class II · Z-0276-2018: Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical c
- Nov 3, 2017 · Class II · Z-0277-2018: Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical c

## 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/K151667
Methodology: https://510kreport.com/methodology