# K014124: Numed Coefficient PTV Catheters

- Pathway: 510(k) (Special)
- Applicant: NuMED, Inc.
- Decided: Jan 16, 2002 after 30 days
- Product code: OMZ (Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter)
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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 Z-MED PTV Catheter: named in the summary without a submission number

## 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. = 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/K014124
Methodology: https://510kreport.com/methodology