# K073326: NRG Transseptal Needle

- Pathway: 510(k) (Traditional)
- Applicant: Baylis Medical Co., Inc.
- Decided: May 28, 2008 after 183 days
- Product code: DXF (Catheter, Septostomy)
- Device class: 2
- Regulation: 21 CFR 870.5175
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011727 (2002). 2 ancestors in all.
16 later devices descend from it; 5 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031949: Toronto RF Septostomy Catheter, Model TSC-50-75, Baylis Medical Co., Inc. (2003) Summary page 1.
- K011727: Transseptal Needle/Trocar, Thomas Medical Products, Inc. (2002)

## Most influential descendants
- K150709: ProTrack RF Anchor Wire (2015), 7 descendants of its own
- K232852: Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable (2023), 3 descendants of its own
- K242076: VersaCross™ RF Wire (2024), 2 descendants of its own
- 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
- K240900: HOTWIRE™ RF Guidewire (2024), 2 descendants of its own

## Recalls of this device
- Oct 11, 2016 · Class II · Z-0393-2017: The firm is voluntarily recalling lots of the NRG Transseptal Needle and NRG RF Transseptal Kit due to the possibility for an integrity defect to the Tyvek pouch of the NRG Transseptal Needle.

## Indications for use
Creation of an atrial septal defect in the heart. Secondary applications include transseptal heart access, monitoring intracardiac pressures, sampling blood, and infusing solutions.

Source page: https://510kreport.com/device/K073326
Methodology: https://510kreport.com/methodology