# K012854: Renal Guiding Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corp.
- Decided: Nov 21, 2001 after 89 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K924607 (1993). 1 ancestor in all.
8 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924607: Arrow Fischell Kink Resist Percut Sheath Intro Set, Arrow Intl., Inc. (1993) Summary page 1.

## Most influential descendants
- K081045: Destination Renal Guiding Sheath (2008), 5 descendants of its own
- K122958: Delivery Sheath, Model Adelante Breezeway (2012), 2 descendants of its own
- K210627: Breezeway II (2021), 1 descendant of its own
- K033569: Flowmedica Bifurcated Infusion System, Infusion Catheter and Introducer Sheath (2004), 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

## Recalls of this device
- Nov 6, 2015 · Class II · Z-2033-2017: Based on internal investigation and testing that revealed the distal end of certain lots of Terumo Medical Destination¿ products may not contain the labeled 5 cm of coating. While there have been no c
- Jun 24, 2010 · Not classified · Z-2417-2011: Molding defect in destination product that render the device unusable.

## Indications for use
The 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/K012854
Methodology: https://510kreport.com/methodology