# K130843: Safesept Needle Free Transseptal Trocar Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Oscor, Inc.
- Decided: Jan 8, 2014 after 287 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K172893: SafeSept Needle Free Transseptal Guidewire (2017), 0 descendants of its own

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

Source page: https://510kreport.com/device/K130843
Methodology: https://510kreport.com/methodology