Feb 10th,2022, ShanghaiHeartCareMedialTechnologyCo., Ltd. has obtained FDA(510k) registration approval by U.S. Food and Drug Administration(FDA)for its SUPSELEK micro catheter.
The FDA(510k) approval means SUPSELEK’s safety and efficacy has been recognized by U.S. FDA and demontrates HearCare’s high quality maunfacturing capability , laying a solid foudation for the company’s further exploration in overseas market.
Product Characteristics
1-Softer tip, safer procedure
Unique laser-treated atraumatic tip
2-Higher visualization, clearer positioning
Distal marker of platinum-iridium alloy
3-Good support and torque ability
Perfect balance of proximal support and distal softness with multi-segment design
4-Better navigation
Hydrophilic coated surface reduces push resistance