# K241042: SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)

- Pathway: 510(k) (Special)
- Applicant: Pressure Products Medical Device Manufacturing, LLC
- Decided: May 17, 2024 after 30 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: 7 generations back to K964518 (1997). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172950: TSN Transseptal Needle, Pressure Products Medical Device Manufacturing, LLC (2018) Summary page 5.

## 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/K241042
Methodology: https://510kreport.com/methodology