# K081986: Safesept Transseptal Trocar Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Oscor, Inc.
- Decided: Nov 14, 2008 after 123 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.
2 later devices descend 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K170671: SafeSept Transseptal Guidewire (2017), 1 descendant of its own
- K221707: SafeSept® Transseptal Guidewire (SS-140) (2022), 0 descendants of its own

## Indications for use
The SafeSept Transseptal Trocar Guldewire is indicated for use In procedures where access to the left atrium via the transseptal technique is desired. The SafeSept Transseptal Trocar Guidewire is Indicated for single use only,

Source page: https://510kreport.com/device/K081986
Methodology: https://510kreport.com/methodology