# K072278: BRK Transseptal Needle

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: Sep 13, 2007 after 28 days
- Product code: DRC (Trocar)
- Device class: 2
- Regulation: 21 CFR 870.1390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K964518 (1997). 6 ancestors in all.
8 later devices descend from it; 3 cite 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)
- K011727: Transseptal Needle/Trocar, Thomas Medical Products, Inc. (2002)
- K070417: Across Transseptal Access System, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984, St Jude Medical (2007) Summary page 1.

## Most influential descendants
- 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
- K212625: PathBuilder Transseptal Needle (2022), 0 descendants of its own

## Indications for use
The St. Jude Medical Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access.

Source page: https://510kreport.com/device/K072278
Methodology: https://510kreport.com/methodology