# K210328: SafeSept Blunt Needle

- Pathway: 510(k) (Special)
- Applicant: Pressure Products Medical Device Manufacturing, LLC
- Decided: Mar 5, 2021 after 29 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)
- K172934: Needle Free Transseptal Cannula, Pressure Products Medical Device Manufacturing, LLC (2018) Summary page 4.

## Indications for use
The SafeSept Blunt Needle is used in conjunction with a transseptal guidewire to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access. The SafeSept Blunt Needle is intended for single use only.

Source page: https://510kreport.com/device/K210328
Methodology: https://510kreport.com/methodology