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- 2017-04-22 发布于浙江
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11.1 PTCA球囊扩张导管技术要求英文翻译
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Technical requirements for medical device product registration number：
Disposable Sterile PTCA balloon catheter
1、Model / Specifications and divide instructions
1、1 Model
PTCA-XX-XX
Balloon Working Length mm
Balloon nominal Diameter mm
Product Name Code
Model mark example：PTCA—2.0—10 represents balloon nominal outer diameter is 2.0mm and working length is 10mm of disposable Sterile PTCA balloon catheter
1、2 Specifications
PTCA balloon catheter specification list
SpecificationsODLengthThe effective length of the catheterMax guide wire diamet
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