# K102948: Torflex Transseptal Guiding Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Baylis Medical Co., Inc.
- Decided: Apr 1, 2011 after 178 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 3 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K013919 (2002). 1 ancestor in all.
9 later devices descend from it; 2 cite it directly.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013919: Torflex Transseptal Guiding Sheath, Baylis Medical Co., Inc. (2002) Summary page 1.

## Most influential descendants
- K182064: ExpanSure Transseptal Dilation System (2019), 5 descendants of its own
- K201288: ExpanSure Large Access Transseptal Dilator (2020), 4 descendants of its own
- K220414: VersaCross Connect Transseptal Dilator (2022), 3 descendants of its own
- K183655: VersaCross Transseptal Sheath (2019), 2 descendants of its own
- K241720: VersaCross Connect™ Transseptal Dilator (2024), 1 descendant of its own

## Recalls of this device
- Oct 7, 2019 · Class II · Z-2069-2020: There is a remote potential for the sterile packaging of lots of the transseptal guiding sheath to be compromised during shipping and handling. In the case that a packaging defect is not identified an
- Oct 7, 2019 · Class II · Z-2070-2020: There is a remote potential for the sterile packaging of the transseptal guiding sheath to be compromised during shipping and handling. In the case that a packaging defect is not identified and the pr
- Sep 23, 2013 · Class I · Z-0085-2014: The TorFlex Transseptal Guiding Sheath Kits are being recalled due to the possibility that the sheath could remove particulate of less than 5 mm from the dilator. The particulate could potentially mig

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

Source page: https://510kreport.com/device/K102948
Methodology: https://510kreport.com/methodology