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Radiofrequency Ablation Catheter from Japan

Steerable cardiac catheter delivering RF energy through irrigated tip for pulmonary vein isolation in atrial fibrillation treatment. Electro-surgical apparatus under HTS 9018.90.60.00 for therapeutic tissue ablation in electrophysiology labs. Includes temperature sensors and irrigation ports.

Duty Rate — Japan → United States

12.5%

Rate breakdown

9903.05.4912.5%Except for products described in headings 9903.05.85–9903.05.92, articles the product of Japan, with an ad valorem (or ad valorem equivalent) rate of duty under column 1 less than 12.5 percent, as provided for in U.S. note 52 to this subchapter

Import Tips

• PMA (Premarket Approval) letters mandatory for Class III cardiac ablation devices

• Include biocompatible coating validation for intravascular contact

• Declare steerable mechanism specifications avoiding mechanical classification