# K232852: Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable

- Pathway: 510(k) (Traditional)
- Applicant: Cross Vascular, Inc.
- Decided: Oct 12, 2023 after 28 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: 2 generations back to K011727 (2002). 3 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073326: NRG Transseptal Needle, Baylis Medical Co., Inc. (2008) Summary page 5.

## Most influential descendants
- K241414: CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W,  CW-1012C); CrossWise RF Adapter Cable (Model CW-1002) (2024), 2 descendants of its own
- K251007: CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) (2025), 0 descendants of its own
- K243193: Cross Wise™ Multi-Use RF Adapter Cable (2024), 0 descendants of its own

## Indications for use
The Cross Vascular RF Transseptal Needle and Connection Cable are used to create an atrial septal defect in the heart. Secondary indications include infusing solutions including heparinized saline and mixtures of 50% contrast media and 50% saline.

Source page: https://510kreport.com/device/K232852
Methodology: https://510kreport.com/methodology