# K262392: APRO 35 Swift Catheter

- Pathway: 510(k) (Special)
- Applicant: Alembic, LLC
- Decided: Aug 12, 2026 after 29 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: 8 generations back to K003880 (2001). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251014: APRO 45 Catheter, Alembic, LLC (2025) Summary page 5.

## Indications for use
The APRO® 35 Swift 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® 35 Swift Catheter is also indicated for use as a conduit for retrieval devices.

Source page: https://510kreport.com/device/K262392
Methodology: https://510kreport.com/methodology