# K013919: Torflex Transseptal Guiding Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Baylis Medical Co., Inc.
- Decided: Feb 22, 2002 after 87 days
- Product code: DBY (Fab, Rhodamine, Antigen, Antiserum, Control)
- Device class: 1
- Regulation: 21 CFR 866.5520
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 1 cites 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K102948: Torflex Transseptal Guiding Sheath (2011), 9 descendants of its own
- 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

## Recalls of this device
- Feb 8, 2010 · Not classified · Z-0816-2010: Radiopaque soft tip may fracture.

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

Source page: https://510kreport.com/device/K013919
Methodology: https://510kreport.com/methodology