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Update-Disposable SC PTCA balloon dilatation catheter with CE mark

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 should be noted before using PTCA balloon to dilate catheter?  

Please read all instructions, warnings and precautions carefully before use. Failure to do so may result in complications.  

PTCA balloon dilatation catheters consist of a single-lumen catheter and a double-lumen catheter, including an inflatable semi-compliant balloon on a fast-exchange (RX) catheter. This is an RX design, so it is assembled from a combination of a single cavity and a double cavity. Balloon inflation was performed by diluting 50% of the contrast medium to normal saline 1:1 using the lumen from proximal catheter to the end of the balloon.  

The second lumen of the PTCA balloon dilatation catheter is guided by a guide wire from the RX port portion to the end end into and through the stenosis to be dilated. The distal axis of the PTCA balloon dilator catheter, including the folded balloon, is coated with a hydrophilic coating.

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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