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U.S. Department of Health and Human Services

Product Classification

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Device drug-coated peripheral transluminal angioplasty catheter
Definition Balloon dilatation of native and/or synthetic arteriovenous dialysis fistulae to establish or maintain patency
Physical State The balloon catheter is generally constructed of synthetic materials such as plastic and introduced into the body using a guidewire. The balloon is generally manufactured in multiple diameters and lengths to allow for treatment of different lesion sizes. There is typically a drug coating on the balloon with assists in maintaining vessel patency.
Technical Method The balloon catheter uses mechanical force across a lesion to establish patency. The drug coating serves as an adjunct to the mechanical action of balloon angioplasty and assists in maintaining vessel patency post-procedure.
Target Area Synthetic and/or native arteriovenous dialysis fistulae.
Review Panel Cardiovascular
Product CodePRC
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Peripheral Interventional Devices Branch (PIDB)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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