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U.S. Department of Health and Human Services

Product Classification

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Device balloon aortic valvuloplasty
Definition A balloon aortic valvuloplasty catheter is indicated for balloon valvuloplasty of the aortic valve.
Physical State Generally, a balloon aortic valvuloplasty catheter is a coaxial catheter comprised of outer and inner layers. The catheter features a molded proximal end bifurcated with two distinct luminal passages. The inflation lumen terminates into a distally mounted balloon made of polyamide. Upon reaching a specified pressure, the waist will expand to the rated balloon diameter and dilate the valve to the rated diameter.
Technical Method The catheter is inserted into the body and directed towards the aortic valve. Once the catheter is placed in the valve, the balloon is expanded which compresses and/or breaks the material causing stenosis.
Target Area The aortic valve of the heart.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeOZT
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Vascular Surgery Devices Branch (VSDB)
Submission Type 510(k)
Regulation Number 870.1255
Device Class 2
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