# K221707: SafeSept® Transseptal Guidewire (SS-140)

- Pathway: 510(k) (Special)
- Applicant: Pressure Products Medical Device Manufacturing, LLC
- Decided: Sep 14, 2022 after 93 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: 2 generations back to K081986 (2008). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170671: SafeSept Transseptal Guidewire, Pressure Products Medical Device Manufacturing, LLC (2017) Summary page 4.

## Indications for use
SafeSept® is indicated for use in procedures where access to the left atrium via the transseptal technique is desired. The SafeSept® Transseptal Guidewire is intended for single use only.

Source page: https://510kreport.com/device/K221707
Methodology: https://510kreport.com/methodology