# K193125: R2P Destination Slender Guiding Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corporation
- Decided: Jan 6, 2020 after 55 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K924607 (1993). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171491: R2P Destination Slender Guiding Sheath, Terumo Medical Corporation (2017) Summary page 5.

## Most influential descendants
- K261242: SimplGuide (2026), 0 descendants of its own

## Indications for use
R2P™ Destination Slender™ Guiding Sheath is indicated for the introduction of interventional and diagnostic devices into the human vasculature through an access site, including but not limited to the radial artery.

Source page: https://510kreport.com/device/K193125
Methodology: https://510kreport.com/methodology