# K040830: Pta, PTV, Atrioseptostomy, Angiographic, Sizing Catheters - Pathway: 510(k) (Special) - Applicant: NuMED, Inc. - Decided: Jun 18, 2004 after 79 days - Product code: DQO (Catheter, Intravascular, Diagnostic) - Device class: 2 - Regulation: 21 CFR 870.1200 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 2 generations back to K931009 (1993). 19 ancestors in all. 1 later device descends from it; 1 cites it directly. 0 of 21 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K003902: Multitrack Angiographic Catheter, NuMED, Inc. (2001) Summary page 1. - K003972: Numed Ghost II Pta Catheters, NuMED, Inc. (2001) Summary page 1. - K003643: Numed Z-Med PTV Catherers, NuMED, Inc. (2000) Summary page 1. - K003276: Tyshak Mini Pediatric PTV Catheter, Model 107, NuMED, Inc. (2000) Summary page 1. - K003114: Numed Tyshak and Z-Med PTV Catheters, NuMED, Inc. (2000) Summary page 1. - K003052: Numed Tyshak II and Z-Med II PTV Catheters, NuMED, Inc. (2000) Summary page 1. - K991977: Tyshak, Model 102 and Z-Med, Model 302, NuMED, Inc. (2000) Summary page 1. - K001804: Numed Z-5 Atrioseptostomy Catheter, NuMED, Inc. (2000) Summary page 1. - K960070: Numed Atrioseptostomy Catheter, NuMED, Inc. (1996) Summary page 1. - K931009: Tyshak Peripheral Balloon Dilation Catheter, NuMED, Inc. (1993) Summary page 1. - K010880: Numed High Pressure Pta Catheters, NuMED, Inc. (2001) Summary page 1. - K952984: Map Multitrack Angiographic Catheter (4F), Map Medical Equipment, Inc. (1996) Summary page 1. - K030589: Modification to Numed Tyshak II and Z-Med II PTV Catheters, NuMED, Inc. (2003) Summary page 1. - K032591: Numed Tyshak Mini Pediatric PTV Catheter, NuMED, Inc. (2003) Summary page 1. - K014124: Numed Coefficient PTV Catheters, NuMED, Inc. (2002) Summary page 1. - K003320: Pta-OS Sizing Balloon, Model 360, NuMED, Inc. (2001) Summary page 1. - K013601: Numed Mullins Pta Catheter, NuMED, Inc. (2002) Summary page 1. - K011557: Pta, PTV, Atrioseptostomy, Angiographic, Sizing Catheters, NuMED, Inc. (2001) Summary page 1. - K022722: Pta and PTV, NuMED, Inc. (2002) Summary page 1. ## Most influential descendants - K153069: Edwards Balloon Catheter (2016), 0 descendants of its own ## Indications for use Multi-Track Angiopraphic Catheter (K952984, K003902) - Recommended for use in catheterization for angiography of cardiovascular vessels and/or chambers. It can be used for injection of contrast medium and pressure measurement in any chamber or vessel. Ghost II PTA (K003972, K011557) - 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. Z-MED Catheter (K991977, K003114, K003643, K011557) - 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; (K931009, K011557) 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 Mini Pediatric PTV Catheter (K003276, K011557, K032591) - 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. Tyshak Catheter (K991977, K003114, K011557) - 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; (K931009, K011557) 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 II Catheter (K003052, K011557, K030589) - 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 II Catheter (K003052, K011557, K030589) - 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; High Pressure PTA (Marauder) (K010880, K011557) - This iliac, 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. Z-5 Atrioseptostomy (K960070, K011557) - Used for the palliation of several congenital heart defects: transposition of the great arteries, total anomalous pulmonary venous drainage without pulmonary obstruction, tricuspid atresia, mitral stenosis, mitral atresia, and pulmonary atresia with intact ventricular septum. Z-5 Braided Atrioseptostomy (K001804, K011557) - Used for the palliation of several congenital heart defects: transposition of the great arteries, total anomalous pulmonary venous drainage without pulmonary obstruction, tricuspid atresia, mitral stenosis, mitral atresia, and pulmonary atresia with intact ventricular septum. Tyshak X Catheter (K022722)- 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. Tyshak II X Catheter (K022722) - 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. Z-MED X Catheter (K022722)- 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. Z-MED II X Catheter (K022722) - 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. COEfficient Catheter (K014124) - 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. Ghost PTA (K931009, K011557) - 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. Mullins PTA (K013601) - 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. Mullins X PTA (K022722) - 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. PTS (K003320, K011557) - For use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device. Source page: https://510kreport.com/device/K040830 Methodology: https://510kreport.com/methodology