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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K260416
Device Name ZYLOX Hippo PTA Balloon Dilatation Catheter
Applicant
Zylox Medtech Co., Ltd.
Rm. 406, 4th Floor, Block B, # 270, Shuyun Rd.
Cangqian Sub-District, Yuhang District
Hangzhou,  CN 311121
Applicant Contact Wanying Xie
Correspondent
Zylox Medtech Co., Ltd.
Rm. 406, 4th Floor, Block B, # 270, Shuyun Rd.
Cangqian Sub-District, Yuhang District
Hangzhou,  CN 311121
Correspondent Contact Siran Wu
Regulation Number870.1250
Classification Product Code
LIT  
Date Received02/09/2026
Decision Date 09/21/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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