# K081045: Destination Renal Guiding Sheath

- Pathway: 510(k) (Special)
- Applicant: Terumo Medical Corp.
- Decided: May 28, 2008 after 44 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: 2 generations back to K924607 (1993). 2 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012854: Renal Guiding Sheath, Terumo Medical Corp. (2001)

## Most influential descendants
- K122958: Delivery Sheath, Model Adelante Breezeway (2012), 2 descendants of its own
- K210627: Breezeway II (2021), 1 descendant of its own
- K242756: Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090) (2024), 0 descendants of its own
- K172995: Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath (2017), 0 descendants of its own
- K140641: Vessix Guide Sheath 7F, 45 CM, RDC, Vessix Guide Sheath 7F, 45CM, Lima (2014), 0 descendants of its own

## Indications for use
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/K081045
Methodology: https://510kreport.com/methodology