# K991977: Tyshak, Model 102 and Z-Med, Model 302

- Pathway: 510(k) (Traditional)
- Applicant: NuMED, Inc.
- Decided: Sep 27, 2000 after 474 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- 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 K931009 (1993). 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)
- K931009: Tyshak Peripheral Balloon Dilation Catheter, NuMED, Inc. (1993) 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) for pulmonary applications. A patient with isolated stenosis. A patient with valvular stenosis with other minor congenital heart disease that does not require surgical intervention.

Source page: https://510kreport.com/device/K991977
Methodology: https://510kreport.com/methodology