# K190688: VersaCross Steerable Sheath, VersaCross Transseptal Dilator

- Pathway: 510(k) (Special)
- Applicant: Baylis Medical Company, Inc.
- Decided: Apr 17, 2019 after 30 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: 1 generation back to K122926 (2013). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122926: Sureflex Steerable Guiding Sheath Kit, Baylis Medical Co., Inc. (2013) Summary page 4.

## Most influential descendants
- K232037: Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath (2024), 0 descendants of its own

## Indications for use
The VersaCross Steerable Sheath and VersaCross Transseptal Dilator is indicated for introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.

Source page: https://510kreport.com/device/K190688
Methodology: https://510kreport.com/methodology