# K172995: Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corporation
- Decided: Nov 21, 2017 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: 5 generations back to K924607 (1993). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 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.
- K091329: Pinnacle Destination Peripheral Guiding Sheath, Terumo Medical Corp. (2009) Summary page 5.
- K081045: Destination Renal Guiding Sheath, Terumo Medical Corp. (2008) Summary page 5.

## Indications for use
The Destination® Carotid Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the carotid arteries. The Destination® Peripheral Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to lower extremity access via a contralateral approach. The Destination® Renal Guiding Sheath is intended for the introduction of interventional and diagnostic devices into the human vasculature including but not limited to the renal arteries.

Source page: https://510kreport.com/device/K172995
Methodology: https://510kreport.com/methodology