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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 Circulatory Support, Structural and Vascular Devices (DHT2B)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible