# K172950: TSN Transseptal Needle

- Pathway: 510(k) (Traditional)
- Applicant: Pressure Products Medical Device Manufacturing, LLC
- Decided: Feb 21, 2018 after 148 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: 6 generations back to K964518 (1997). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122587: BRK Transseptal Needle Model 407200, 407201, 407205, 407206, 407207, G407208, St Jude Medical (2013) Summary page 4.

## Most influential descendants
- K241042: SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) (2024), 0 descendants of its own

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

Source page: https://510kreport.com/device/K172950
Methodology: https://510kreport.com/methodology