# K052185: Destination Carotid Guiding Sheath

- Pathway: 510(k) (Special)
- Applicant: Terumo Medical Corp.
- Decided: Sep 6, 2005 after 26 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 1 (0 Class I)
- 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.
7 later devices descend from it; 3 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)
- K012812: Carotid Guiding Sheath, Terumo Medical Corp. (2001) Summary page 1.

## Most influential descendants
- K171491: R2P Destination Slender Guiding Sheath (2017), 3 descendants of its own
- K193125: R2P Destination Slender Guiding Sheath (2020), 1 descendant of its own
- K070166: Strada Carotid Guiding Sheath (2007), 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

## Recalls of this device
- Jun 24, 2010 · Not classified · Z-2416-2011: Molding defect in destination product that render the device unusable.

## 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.

Source page: https://510kreport.com/device/K052185
Methodology: https://510kreport.com/methodology