# K140641: Vessix Guide Sheath 7F, 45 CM, RDC, Vessix Guide Sheath 7F, 45CM, Lima

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Jul 3, 2014 after 113 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.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081045: Destination Renal Guiding Sheath, Terumo Medical Corp. (2008) Summary page 1.

## Indications for use
The Vessixm Guide Sheath is designed to be used for the introduction of interventional and diagnostic devices through the vasculature to the renal arteries.

Source page: https://510kreport.com/device/K140641
Methodology: https://510kreport.com/methodology