# K030589: Modification to Numed Tyshak II and Z-Med II PTV Catheters

- Pathway: 510(k) (Special)
- Applicant: NuMED, Inc.
- Decided: May 21, 2003 after 85 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
No predicates in its family tree.
14 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) NuMED Tyshak and Z-MED PTV Catheters: named in the summary without a submission number

## Most influential descendants
- K073166: Endowave Infusion System (2008), 11 descendants of its own
- K081467: Ekosonic Endovascular System with Rapid Pulse Modulation (2008), 10 descendants of its own
- K111705: Ekosonic Endovascular System (2011), 9 descendants of its own
- K183290: Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200 (2019), 8 descendants of its own
- K192864: UNI*FUSE Infusion System with Cooper Wire (2020), 2 descendants of its own

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

Source page: https://510kreport.com/device/K030589
Methodology: https://510kreport.com/methodology