# K070417: Across Transseptal Access System, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: Jun 5, 2007 after 113 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). 4 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052644: Swartz Braided Transseptal Guiding Introducer, St Jude Medical (2005) Summary page 1.

## Cited in the summary but kept off the family tree
- K071727: QXT Extraction Catheter, Vascular Solutions, Inc. (2007). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K072278: BRK Transseptal Needle (2007), 8 descendants of its own
- K122587: BRK Transseptal Needle Model 407200, 407201, 407205, 407206, 407207, G407208 (2013), 6 descendants of its own
- K172950: TSN Transseptal Needle (2018), 1 descendant of its own
- K172934: Needle Free Transseptal Cannula (2018), 1 descendant of its own
- K241042: SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) (2024), 0 descendants of its own

## Indications for use
The St. Jude Medical ACrossTM Transseptal Access System is used both to puncture the interatrial septum during a transseptal catheterization procedure and to introduce various cardiovascular catheters into the left side of the heart.

Source page: https://510kreport.com/device/K070417
Methodology: https://510kreport.com/methodology