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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 K853701
Device Name JELCO & CATHLON IV STRIPED IV CATHETERS-RADIOPAGUL
Applicant
Critikon Company, LLC
West Queen St.
Southington,  CT  06489
Applicant Contact MELANIE SABO
Correspondent
Critikon Company, LLC
West Queen St.
Southington,  CT  06489
Correspondent Contact MELANIE SABO
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received09/04/1985
Decision Date 10/17/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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