# K253799: SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)

- Pathway: 510(k) (Special)
- Applicant: Pressure Products Medical Device Manufacturing, LLC
- Decided: Mar 13, 2026 after 105 days
- Product code: DXF (Catheter, Septostomy)
- Device class: 2
- Regulation: 21 CFR 870.5175
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K011727 (2002). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242076: VersaCross™ RF Wire, Baylis Medical Company (2024) Summary page 5.

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

Source page: https://510kreport.com/device/K253799
Methodology: https://510kreport.com/methodology