# K061015: Fast-Cath Hemostasis Introducer and Transseptal Introducer

- Pathway: 510(k) (Special)
- Applicant: St Jude Medical
- Decided: Aug 3, 2006 after 112 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: 3 generations back to K964518 (1997). 5 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982187: Fast-Cath Intra-Cardiac Introducer, Daig Corp. (1998) Summary page 1.
- K973840: Fast-Cath (TM) Intra-Cardiac Introducer, Daig Corp. (1998) Summary page 1.
- K052644: Swartz Braided Transseptal Guiding Introducer, St Jude Medical (2005) Summary page 1.
- K964518: Fast-Cath Transseptal Catheter Introducer, Daig Corp. (1997) Summary page 1.

## Most influential descendants
- K101497: Delivery Sheath, Model Adelante Breezeway (2010), 8 descendants of its own
- K120459: Steerable Guiding Sheath, Model Adelante Destino (2012), 7 descendants of its own
- K151951: Destino Reach (2015), 6 descendants of its own
- K240829: AuST Steerable Sheath (2024), 5 descendants of its own
- K242106: AuST Steerable Sheath (2024), 4 descendants of its own

## Indications for use
The Fast-Cath Transseptal Introducer is indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum. The Fast-Cath hemostasis introducer is indicated for the introduction of various cardiovascular catheters or biopsy devices into the heart.

Source page: https://510kreport.com/device/K061015
Methodology: https://510kreport.com/methodology