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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 K254212
Device Name NC PTA Balloon Dilatation Catheter
Applicant
Kossel Medtech (Suzhou) Co., Ltd.
Bldg. 6,# 8 Jinfeng Rd.
Suzhou New District,  CN 215163
Applicant Contact Haifeng Xie
Correspondent
Kossel Medtech (Suzhou) Co., Ltd.
Bldg. 6,# 8 Jinfeng Rd.
Suzhou New District,  CN 215163
Correspondent Contact Haifeng Xie
Regulation Number870.1250
Classification Product Code
LIT  
Date Received12/29/2025
Decision Date 09/16/2026
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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