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Update-Semi compliance PTCA balloon dilatation catheter with FDA

PTCA balloon catheter is mainly used to dilate patients' stenosis of coronary artery lesions and improve myocardial blood flow through minimally invasive interventional surgery (PCI).  It can also be used to deliver release stents to patients with coronary artery stenosis.
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What is a PTCA balloon catheter?  

PTCA balloon dilatation catheter is a rapid replacement balloon catheter. The balloon is made of polyamide and the proximal tube is made of teflon coated stainless steel, with two opaque markers made of platinum-iridium alloy at each end of the balloon.  

What are the characteristics of PTCA balloon dilatation catheter?  

PTCA balloon dilators currently on the market combine the competitive characteristics of ideal primary balloon dilators.  

1. The diameter of the balloon is 1.00-4.00 mm and the length is 10-30 mm.  

2. PTCA balloon dilator catheter has a hydrophilic coating from the distal balloon neck to the Rx port for smooth navigation. 5 mm long tip with 1.50 mm and 2.00 mm air bag to achieve distal stability and guide wire support  

3. Nominal pressure is 6ATM  

4. Rated rupture pressure is 16ATM  

Balloon Compliance and Rated Burst Pressure:

P/atm D/mmTolerance of Compliance:±5%
6 (NP)810121416 (RBP)18
1.51.501.531.561.591.621.651.68
2.02.002.032.062.092.122.152.18
2.52.502.542.582.612.642.672.70
2.752.752.792.832.862.892.922.95
3.03.003.043.083.113.143.173.21
3.53.503.553.603.643.693.733.77
4.04.004.054.104.154.204.254.30

Size Matrix of PTCA Balloon Catheter:

L/mm
D/mm
10152025303540
1.5---
2.0--
2.5
2.75
3.0
3.5
4.0



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