# K161546: R2P SlenGuide

- Pathway: 510(k) (Traditional)
- Applicant: Ashitaka Factory of Terumo Corporation
- Decided: Oct 14, 2016 after 133 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 K972978 (1997). 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)
- K972978: Vista Brite Tip Guiding Catheters, Cordis Corp. (1997) Summary page 5.

## Indications for use
The R2P (radial to peripheral) SlenGuide is designed for the introduction of interventional and diagnostic devices into the peripheral vasculature of the lower extremities.

Source page: https://510kreport.com/device/K161546
Methodology: https://510kreport.com/methodology