# K261745: LightningWire Transseptal Puncture System (TPS)

- Pathway: 510(k) (Traditional)
- Applicant: ElectroWire Medical
- Decided: Jun 26, 2026 after 30 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: 3 generations back to K011727 (2002). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150709: ProTrack RF Anchor Wire, Baylis Medical Company, Inc. (2015) Summary page 5.

## Indications for use
The LightningWire TPS is used to create an atrial septal defect in the heart, whereby various cardiovascular catheters are introduced.

Source page: https://510kreport.com/device/K261745
Methodology: https://510kreport.com/methodology