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DK Score ™

Coronary Scoring Balloon Dilatation Catheter

NMPA Approval 20233031975

The coronary scoring balloon dilation catheter packaged as sterile and intended for single use in a radiology suite/catheterization laboratory/operating room in conjunction with radiologic equipment for fluoroscopic imaging. The product is a rapid exchange catheter, which is made of Pebax and nylon material with a PTFE jacket covering the stainless steel hypo-tube. The device consists of a catheter with a non-compliant balloon attached at the distal tip. 3 scoring wires are attached on the surface of the balloon. The product is indicated for dilatation of intravascular stenotic lesions during coronary angioplasty.

No Size Balloon nominal diameter (mm) Balloon nominal length (mm) Nominal pressure(atm) Rated burst pressure (atm)
1 CSL-1710 1.75 10 10 20
2 CSL-1715 1.75 15 10 20
3 CSL-1720 1.75 20 10 20
4 CSL-1725 1.75 25 10 20
5 CSL-1730 1.75 30 10 20
6 CSL-2010 2.00 10 10 20
7 CSL-2015 2.00 15 10 20
8 CSL-2020 2.00 20 10 20
9 CSL-2025 2.00 25 10 20
10 CSL-2030 2.00 30 10 20
11 CSL-2210 2.25 10 10 20
12 CSL-2215 2.25 15 10 20
13 CSL-2220 2.25 20 10 20
14 CSL-2225 2.25 25 10 20
15 CSL-2230 2.25 30 10 20
16 CSL-2510 2.50 10 10 20
17 CSL-2515 2.50 15 10 20
18 CSL-2520 2.50 20 10 20
19 CSL-2525 2.50 25 10 20
20 CSL-2530 2.50 30 10 20
21 CSL-2710 2.75 10 10 20
22 CSL-2715 2.75 15 10 20
23 CSL-2720 2.75 20 10 20
24 CSL-2725 2.75 25 10 20
25 CSL-2730 2.75 30 10 20
26 CSL-3010 3.00 10 10 20
27 CSL-3015 3.00 15 10 20
28 CSL-3020 3.00 20 10 20
29 CSL-3025 3.00 25 10 20
30 CSL-3030 3.00 30 10 20
31 CSL-3210 3.25 10 10 20
32 CSL-3215 3.25 15 10 20
33 CSL-3220 3.25 20 10 20
34 CSL-3225 3.25 25 10 20
35 CSL-3230 3.25 30 10 20
36 CSL-3510 3.50 10 10 20
37 CSL-3515 3.50 15 10 20
38 CSL-3520 3.50 20 10 20
39 CSL-3525 3.50 25 10 20
40 CSL-3530 3.50 30 10 20
41 CSL-3710 3.75 10 10 20
42 CSL-3715 3.75 15 10 20
43 CSL-3720 3.75 20 10 20
44 CSL-3725 3.75 25 10 20
45 CSL-3730 3.75 30 10 20
46 CSL-4010 4.00 10 10 20
47 CSL-4015 4.00 15 10 20
48 CSL-4020 4.00 20 10 20
49 CSL-4025 4.00 25 10 20
50 CSL-4030 4.00 30 10 20

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