11.1 PTCA球囊扩张导管技术要求英文翻译

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1、Technicalrequirementsformedicaldeviceproductregistrationnumber：DisposableSterilePTCAballooncatheter1、Model/Specificationsanddivideinstructions1、1ModelPTCA-XX-XXBalloonWorkingLengthmmBalloonnominalDiametermmProductNameCodeModelmarkexample：PTCA—2.0—10representsballoonnominalouterdiame

2、teris2.0mmandworkinglengthis10mmofdisposableSterilePTCAballooncatheter1、2SpecificationsPTCAballooncatheterspecificationlistSpecificationsODLengthTheeffectivelengthofthecatheterMaxguidewirediameterNominalpressureRBPDK-PTCA-1.5-101.50mm10mm142cm≦0.014in8ATM16ATMDK-PTCA-1.5-201.50mm20m

3、m142cm≦0.014in8ATM16ATMDK-PTCA-1.5-301.50mm30mm142cm≦0.014in8ATM16ATMDK-PTCA-1.75-101.75mm10mm142cm≦0.014in8ATM16ATMDK-PTCA-1.75-201.75mm20mm142cm≦0.014in8ATM16ATMDK-PTCA-1.75-301.75mm30mm142cm≦0.014in8ATM16ATMDK-PTCA-2.0-102.00mm10mm142cm≦0.014in8ATM16ATMDK-PTCA-2.0-202.00mm20mm142

4、cm≦0.014in8ATM16ATMDK-PTCA-2.0-302.00mm30mm142cm≦0.014in8ATM16ATMDK-PTCA-2.5-102.50mm10mm142cm≦0.014in8ATM16ATMDK-PTCA-2.5-202.50mm20mm142cm≦0.014in8ATM16ATMDK-PTCA-2.5-302.50mm30mm142cm≦0.014in8ATM16ATMDK-PTCA-2.75-102.75mm10mm142cm≦0.014in8ATM16ATMDK-PTCA-2.75-202.75mm20mm142cm≦0.

5、014in8ATM16ATMDK-PTCA-2.75-302.75mm30mm142cm≦0.014in8ATM16ATMDK-PTCA-3.0-103.00mm10mm142cm≦0.014in8ATM16ATMDK-PTCA-3.0-203.00mm20mm142cm≦0.014in8ATM16ATMDK-PTCA-3.0-303.00mm30mm142cm≦0.014in8ATM16ATMDK-PTCA-3.5-103.50mm10mm142cm≦0.014in6ATM16ATMDK-PTCA-3.5-203.50mm20mm142cm≦0.014in6

6、ATM16ATMDK-PTCA-3.5-303.50mm30mm142cm≦0.014in6ATM16ATMDK-PTCA-4.0-104.00mm10mm142cm≦0.014in6ATM16ATMDK-PTCA-4.0-204.00mm20mm142cm≦0.014in6ATM16ATMDK-PTCA-4.0-304.00mm30mm142cm≦0.014in6ATM16ATM1、3DivideinstructionsDisposableSterilePTCAballooncatheterconsistsofballoon,connectingcathet

7、er,tip,supportcatheterandHandle.Accordingtodifferentballoondiametertodividetheballoonintodifferentspecificationsandsizes.Accordingtomedicaldeviceclassificationrules6877,theballooncatheterbelongingtoClassⅢinterventionalequipmentintravascularcatheter.2、Performance2、1AppearanceAswithno

8、rmalvisionorcorrect