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U.S. Department of Health and Human Services

Product Classification

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Device pulmonary (pulmonic) valvuloplasty catheters/percutaneous valvuloplasty catheter
Regulation Description Percutaneous catheter.
Definition Catheter is used for Percutaneous Transluminal or balloon Valvuloplasty (PTV) of the pulmonary (pulmonic) valve. Used on patients with isolated pulmonary stenosis and also on patients with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.
Physical State The device is a catheter with a balloon tip.
Technical Method Catheter contains a ballon at the distal end of the shaft. The catheter is inserted into the body and directed towards the pulmonary 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 target area is the pulmonary valve of the heart.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeOMZ
Premarket Review Circulatory Support, Structural and Vascular Devices (DHT2B)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type 510(k)
Regulation Number 870.1250
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible