# K233350: SINC Support Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Reflow Medical, Inc.
- Decided: Feb 8, 2024 after 132 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: 11 generations back to K001992 (2000). 29 ancestors in all.
No later device cites it as a predicate yet.
1 of 30 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200094: speX LP Support Catheter, Reflow Medical (2020) Summary page 5.

## Indications for use
SINC Support Catheters are intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. They may be used to facilitate placement and exchange of guidewires and other interventional devices, and provide a conduit for delivery of saline solutions or diagnostic/ therapeutics agents.

Source page: https://510kreport.com/device/K233350
Methodology: https://510kreport.com/methodology