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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 K252677
Device Name Polyshield Safety IV Catheters
Applicant
Poly Medicure Limited
Plot # 115-117, Sector-59
Hsiidc Industrial Area, Ballabhgarh
Faridabad,  IN 121004
Applicant Contact S. S. Rawat
Correspondent
Donawa Lifescience
Piazza Albania 10
Rome,  IT 00153
Correspondent Contact Roger Gray
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received08/25/2025
Decision Date 11/05/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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