# DEN080015: Nucleus-X PTV Catheter

- Pathway: De Novo (Post-NSE)
- Applicant: NuMED, Inc.
- Decided: Jun 11, 2012 after 1,265 days
- Product code: OZT (Balloon Aortic Valvuloplasty)
- Device class: 2
- Regulation: 21 CFR 870.1255
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 4 cite 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)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K123111: V8 Transluminal Bav Catheter (2013), 4 descendants of its own
- K132728: V8 Transluminal Bav Catheter (2013), 3 descendants of its own
- K133607: V8 Transluminal Bav Catheter (2014), 2 descendants of its own
- K150343: V8 Transluminal BAV Catheter (2015), 1 descendant of its own
- K220881: Inoue Balloon a (2022), 0 descendants of its own

Source page: https://510kreport.com/device/DEN080015
Methodology: https://510kreport.com/methodology