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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 K914378
Device Name PERIPHERAL INTERVENOUS CATHETER
Applicant
Medical Profiles, Inc.
13324 Farmington Rd.
Lavonia,  MI  48150
Applicant Contact MICHAEL MCAVENIA
Correspondent
Medical Profiles, Inc.
13324 Farmington Rd.
Lavonia,  MI  48150
Correspondent Contact MICHAEL MCAVENIA
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received10/01/1991
Decision Date 05/20/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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