# K042308: Sheath-in-Sheath Catheter, 18FR, Model S00018; Sheath-in-Sheath Catheter, 6 FR., Model S00019

- Pathway: 510(k) (Traditional)
- Applicant: Facile Medical, Inc.
- Decided: Feb 17, 2005 after 176 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The Sheath-in Sheath Catheter is designed to facilitate the entry of interventional devices into the vessels of the cardiovascular system.

Source page: https://510kreport.com/device/K042308
Methodology: https://510kreport.com/methodology