# K260626: Multiflex Steerable Sheath 17.5F

- Pathway: 510(k) (Special)
- Applicant: Vizaramed, Inc.
- Decided: Mar 26, 2026 after 28 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: 5 generations back to K964518 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221655: Multiflex Steerable Sheath, Vizaramed, Inc. (2022) Summary page 6.

## 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/K260626
Methodology: https://510kreport.com/methodology