# K221655: Multiflex Steerable Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Vizaramed, Inc.
- Decided: Nov 14, 2022 after 160 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: 4 generations back to K964518 (1997). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081645: Agilis NXT Steerable Introducer, Model G408324, St Jude Medical (2008) Summary page 5.

## Most influential descendants
- K260626: Multiflex Steerable Sheath 17.5F (2026), 0 descendants of its own

## Indications for use
The VizaraMed Multiflex Steerable Sheath is intended for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

Source page: https://510kreport.com/device/K221655
Methodology: https://510kreport.com/methodology