# K243436: Seclusion Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Basis Medical
- Decided: Feb 28, 2025 after 115 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: 1 generation back to K153488 (2016). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153488: Occlusion Perfusion Catheter, Advanced Catheter Therapies, Inc. (2016) Summary page 5.

## Indications for use
The Seclusion Catheter is indicated for localized infusion and aspiration of various therapeutic and diagnostic agents in isolated segments of the peripheral venous vasculature. The Seclusion Catheter may be repositioned for multiple treatments with the same patient. The Seclusion Catheter is not indicated for use in the neurovasculature.

Source page: https://510kreport.com/device/K243436
Methodology: https://510kreport.com/methodology