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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K252513
Device Name Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)
Applicant
Poly Medicure Limited
Plot # 115-116, Sector-59, Hsiidc Industrial Area
Ballabgarh
Faridabad,  IN 121004
Applicant Contact Ramdas Sharma
Correspondent
Gsa2 Group, LLC
8049 Hayes St. NE
Minneapolis,  MN  55432
Correspondent Contact Sunita Teekasingh
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received08/11/2025
Decision Date 04/01/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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