# K070166: Strada Carotid Guiding Sheath

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: Apr 6, 2007 after 78 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.
1 later device descends from it; 1 cites it directly.
0 of 5 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 1.

## Most influential descendants
- K093130: Engage TR Introducer (2009), 0 descendants of its own

## Indications for use
The StradaTM Carotid Guiding Sheath is indicated for the introduction of diagnostic and therapeutic devices into the human vasculature including, but not limited to the carotid artery.

Source page: https://510kreport.com/device/K070166
Methodology: https://510kreport.com/methodology