# K182064: ExpanSure Transseptal Dilation System

- Pathway: 510(k) (Traditional)
- Applicant: Baylis Medical Company, Inc.
- Decided: Mar 21, 2019 after 232 days
- Product code: DRE (Dilator, Vessel, For Percutaneous Catheterization)
- Device class: 2
- Regulation: 21 CFR 870.1310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K013919 (2002). 2 ancestors in all.
5 later devices descend from it; 1 cites it directly.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102948: Torflex Transseptal Guiding Sheath, Baylis Medical Co., Inc. (2011) Summary page 4.

## Most influential descendants
- K201288: ExpanSure Large Access Transseptal Dilator (2020), 4 descendants of its own
- K220414: VersaCross Connect Transseptal Dilator (2022), 3 descendants of its own
- K241720: VersaCross Connect™ Transseptal Dilator (2024), 1 descendant of its own
- K251325: VersaCross Connect™ Transseptal Dilator (2025), 0 descendants of its own
- K233647: VersaCross Connect™ Transseptal Dilator (2023), 0 descendants of its own

## Indications for use
The ExpanSure Transseptal Dilation System is indicated for use in procedures where access to the left atrium via the transseptal technique is desired.

Source page: https://510kreport.com/device/K182064
Methodology: https://510kreport.com/methodology