# K171491: R2P Destination Slender Guiding Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corporation
- Decided: Oct 5, 2017 after 136 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: 3 generations back to K924607 (1993). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052185: Destination Carotid Guiding Sheath, Terumo Medical Corp. (2005) Summary page 5.

## Most influential descendants
- K193125: R2P Destination Slender Guiding Sheath (2020), 1 descendant of its own
- K261242: SimplGuide (2026), 0 descendants of its own
- K202167: Brite Tip Radianz Guiding Sheath (2021), 0 descendants of its own

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

Source page: https://510kreport.com/device/K171491
Methodology: https://510kreport.com/methodology