# K032591: Numed Tyshak Mini Pediatric PTV Catheter

- Pathway: 510(k) (Special)
- Applicant: NuMED, Inc.
- Decided: Sep 25, 2003 after 34 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003276 (2000). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003276: Tyshak Mini Pediatric PTV Catheter, Model 107, NuMED, Inc. (2000) Summary page 1.

## Most influential descendants
- K040830: Pta, PTV, Atrioseptostomy, Angiographic, Sizing Catheters (2004), 1 descendant of its own
- K153069: Edwards Balloon Catheter (2016), 0 descendants of its own

## Indications for use
This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve in Pediatric applications. . A patient with isolated pulmonary stenosis. . A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.

Source page: https://510kreport.com/device/K032591
Methodology: https://510kreport.com/methodology