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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 K111236
Device Name INTROCAN SAFETY (R) 3 CLOSED IV CATHETER 18GA X 1-3/4 (45MM) AND 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) / 20GA X 1
Applicant
B.Braun Melsungen AG
901 Marcon Blvd.
Allentown,  PA  18109
Applicant Contact ANGELA J CARAVELLA
Correspondent
B.Braun Melsungen AG
901 Marcon Blvd.
Allentown,  PA  18109
Correspondent Contact ANGELA J CARAVELLA
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received05/02/2011
Decision Date 08/30/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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