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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheters, Transluminal Coronary Angioplasty, Percutaneous
510(k) Number K252116
Device Name Firefighter™ Pro PTCA Balloon Catheter
Applicant
Shanghai MicroPort Medical (Group) Co., Ltd.
1601 Zhangdong Rd., Zj Hi-Tech Park
Shanghai,  CN 201203
Applicant Contact Huasheng Li
Correspondent
Shanghai MicroPort Medical (Group) Co., Ltd.
1601 Zhangdong Rd., Zj Hi-Tech Park
Shanghai,  CN 201203
Correspondent Contact Huasheng Li
Regulation Number870.5100
Classification Product Code
LOX  
Date Received07/07/2025
Decision Date 04/07/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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