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July 2nd ,2021 Kossel Selethru® NC PTCA Balloon Dilatation Catheter obtain the FDA 510 (K) certificate

One of Kossel’s main products, NC PTCA Balloon Dilatation Catheter, has received a new international certification, which is the FDA 510 (K) certificate. And it took only two months from the time the FDA received the application documents to the approval. Congratulations to Kossel for getting a better pass.

We usually see compliance/semi- compliance/non- compliance when choose the balloon catheter. Then what is the compliance?
1. Compliance balloon
After the pressure of the compliance balloon increases to the named pressure or expands to a predetermined diameter, its diameter and volume can continue to increase as the filling pressure continues to increase.
2. Semi- compliance balloon
The semi-compliant balloon refers to that when the inflation pressure of the balloon continues to increase between the named pressure and the burst pressure, the diameter of the balloon still has an increase range of about 0.25-0.75mm above the predetermined diameter.
3. Non-compliant balloon
The diameter of the non-compliant balloon remains the same no matter how much pressure is increased after the diameter of the balloon is completely filled to the specified value.
Both of the high pressure resistance and the ability to squeeze lesions are stronger than the compliance balloon, but the adaptability to the shape of the blood vessel is weaker than the compliance balloon.

PTCA Balloon Dilatation

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