# K022722: Pta and PTV

- Pathway: 510(k) (Special)
- Applicant: NuMED, Inc.
- Decided: Sep 13, 2002 after 28 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.
10 later devices descend from it; 3 cite it directly.
0 of 11 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) Tyshak: named in the summary without a submission number
- (no number) Tyshak II: named in the summary without a submission number
- (no number) Z-MED: named in the summary without a submission number
- (no number) Z-Med II: named in the summary without a submission number
- (no number) Mullins: named in the summary without a submission number

## Most influential descendants
- K102473: Mullins-X PTV Catheter (2010), 6 descendants of its own
- K122367: Bard PTV Dilatation Catheter (2012), 5 descendants of its own
- K131002: Vida PTV Dilataton Catheter (2013), 4 descendants of its own
- K141985: True BA V Balloon Valvuloplasty Catheter (2014), 3 descendants of its own
- K212588: Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter (2022), 2 descendants of its own

## Indications for use
Z-MED-X Catheter - This catheter is recommended 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 require surgical intervention. And; This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries. Tyshak-X Catheter - This catheter is recommended 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 require surgical intervention. And; This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries. Tyshak 11-X Catheter - This catheter is recommended 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 require surgical intervention. And; Z-MED 11-XCatheter - This catheter is recommended 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 require surgical intervention. And; Mullins-X PTA - This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.

Source page: https://510kreport.com/device/K022722
Methodology: https://510kreport.com/methodology