# K213584: Reprocessed NRG Transseptal Needle

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Health, LLC
- Decided: Apr 4, 2023 after 508 days
- Product code: QLZ (Septostomy Catheter, Reprocessed)
- 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200060: Reprocessed NRG Transseptal Needle, Innovative Health, LLC (2020) Summary page 5.
- K073326: NRG Transseptal Needle, Baylis Medical Co., Inc. (2008) Summary page 5.

## Indications for use
The Reprocessed NRG Transseptal Needle is used to create an atrial septal defect in the heart. Secondary indications include monitoring intracardiac pressures, sampling blood, and infusing solutions.

Source page: https://510kreport.com/device/K213584
Methodology: https://510kreport.com/methodology