# K170671: SafeSept Transseptal Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Pressure Products Medical Device Manufacturing, LLC
- Decided: Oct 20, 2017 after 228 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: 1 generation back to K081986 (2008). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081986: Safesept Transseptal Trocar Guidewire, Oscor, Inc. (2008) Summary page 4.

## Most influential descendants
- K221707: SafeSept® Transseptal Guidewire (SS-140) (2022), 0 descendants of its own

## Indications for use
The 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/K170671
Methodology: https://510kreport.com/methodology