# K234115: APRO 55 Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Alembic, LLC
- Decided: Mar 15, 2024 after 79 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). 10 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 15 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.

## Most influential descendants
- K251014: APRO 45 Catheter (2025), 1 descendant of its own
- K262392: APRO 35 Swift Catheter (2026), 0 descendants of its own
- K250962: APRO 55 Intermediate Catheter (2025), 0 descendants of its own
- K243297: APRO 70 Swift Catheter (2025), 0 descendants of its own

## Indications for use
The APRO 55 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 APRO 55 Catheter is also indicated for use as a conduit for retrieval devices.

Source page: https://510kreport.com/device/K234115
Methodology: https://510kreport.com/methodology