# K122587: BRK Transseptal Needle Model 407200, 407201, 407205, 407206, 407207, G407208

- Pathway: 510(k) (Special)
- Applicant: St Jude Medical
- Decided: Feb 7, 2013 after 167 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: 5 generations back to K964518 (1997). 7 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072278: BRK Transseptal Needle, St Jude Medical (2007) Summary page 1.

## Most influential descendants
- 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
- K210328: SafeSept Blunt Needle (2021), 0 descendants of its own

## Indications for use
The BRK 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/K122587
Methodology: https://510kreport.com/methodology