# K052644: Swartz Braided Transseptal Guiding Introducer

- Pathway: 510(k) (Special)
- Applicant: St Jude Medical
- Decided: Dec 5, 2005 after 70 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: 2 generations back to K964518 (1997). 3 ancestors in all.
36 later devices descend from it; 4 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964518: Fast-Cath Transseptal Catheter Introducer, Daig Corp. (1997) Summary page 1.
- K042623: Agilis Steerable Catheter Introducer, Model 408304, St. Jude Medical, Daig Division, Inc. (2005) Summary page 1.

## Most influential descendants
- K070417: Across Transseptal Access System, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984 (2007), 11 descendants of its own
- K061015: Fast-Cath Hemostasis Introducer and Transseptal Introducer (2006), 9 descendants of its own
- K101497: Delivery Sheath, Model Adelante Breezeway (2010), 8 descendants of its own
- K083793: Steerable Guide Catheter (2009), 8 descendants of its own
- K072278: BRK Transseptal Needle (2007), 8 descendants of its own

## Indications for use
The St. Jude Medical Transseptal Catheter Introducer Set is used for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.

Source page: https://510kreport.com/device/K052644
Methodology: https://510kreport.com/methodology