Angioplasty balloons
Tyshak II
by B Braun Interventional Systems, Inc
A sterile flexible tube with an inflatable balloon designed to perform plastic or restorative surgery on a cardiac valve, i.e., for the dilatation of atrioventricular, aortic, and pulmonary trunk valves. It is typically used for the percutaneous dilatation of commissural fusion in stenotic mitral valves and for annular, cuspal, and calcific nodular fractures, to improve cuspal mobility in adult calcific aortic stenosis, and for leaflet tearing in pulmonic valve stenosis. It may also be used for percutaneous balloon pericardiotomy. This is a single-use device.
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Where to buy Tyshak II
Contact B Braun Interventional Systems, Inc directly; they can quote, ship, or point you to the distributor for your country.
From bisusa.com, checked October 2026.
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Tyshak II models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| 611553 | Length 6 cm | Not stated | Available |
FDA clearances
- 510(k) K003052 November 2000
- 510(k) K931009 December 1993
Procedures that use angioplasty balloons
Frequently asked questions
What is Tyshak II used for?
A sterile flexible tube with an inflatable balloon designed to perform plastic or restorative surgery on a cardiac valve, i.e., for the dilatation of atrioventricular, aortic, and pulmonary trunk valves. It is typically used for the percutaneous dilatation of commissural fusion in stenotic mitral valves and for annular, cuspal, and calcific nodular fractures, to improve cuspal mobility in adult calcific aortic stenosis, and for leaflet tearing in pulmonic valve stenosis. It may also be used for percutaneous balloon pericardiotomy. This is a single-use device.
Who makes Tyshak II?
Tyshak II is made by B Braun Interventional Systems, Inc. It is listed under peripheral angioplasty balloons in our device library.
What sizes does Tyshak II come in?
Sizes listed for Tyshak II: Length: 6 cm. Confirm availability with the manufacturer's instructions for use.
Is Tyshak II MRI safe?
The FDA device database entry for Tyshak II does not state its MRI safety status. Check the labeling before MRI.
Is Tyshak II FDA cleared?
Tyshak II is covered by FDA submissions K003052, K931009.
How do I contact a B Braun Interventional Systems, Inc sales representative?
B Braun Interventional Systems, Inc has not listed representatives on LA Vascular yet. Visit the B Braun Interventional Systems, Inc company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.