# K183655: VersaCross Transseptal Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Baylis Medical Company, Inc.
- Decided: May 20, 2019 after 144 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 3 (0 Class I)
- 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.
2 later devices descend from it; 2 cite it directly.
1 of 5 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
- K231108: Talon Transseptal Sheath (2023), 0 descendants of its own
- K213492: Dib UltraNav Transseptal Catheter System (2022), 0 descendants of its own

## Recalls of this device
- Jun 10, 2025 · Class II · Z-2103-2025: Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potenti
- Jun 10, 2025 · Class II · Z-2106-2025: Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potenti
- Jun 10, 2025 · Class II · Z-2105-2025: Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potenti

## Indications for use
The VersaCross Transseptal Sheath is used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal perforation / puncture.

Source page: https://510kreport.com/device/K183655
Methodology: https://510kreport.com/methodology