# K153488: Occlusion Perfusion Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Catheter Therapies, Inc.
- Decided: Feb 25, 2016 after 83 days
- Product code: QEY (Mechanical Thrombolysis Catheter)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K243436: Seclusion Catheter (2025), 0 descendants of its own

## Indications for use
The Occlusion Perfusion Catheter™ is indicated for localized infusion or irrigation of various diagnostic and therapeutic agents into the peripheral vasculature. The Occlusion Perfusion Catheter™ may be repositioned for multiple treatments with the same patient. It is not indicated for use in the neurovasculature.

Source page: https://510kreport.com/device/K153488
Methodology: https://510kreport.com/methodology