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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 K881666
Device Name HR(TM) INTRAVASCULAR CATHETER
Applicant
Icu Medical, Inc.
23436 Madero St.
Mission Viejo,  CA  92691
Applicant Contact FRED MCLENDON
Correspondent
Icu Medical, Inc.
23436 Madero St.
Mission Viejo,  CA  92691
Correspondent Contact FRED MCLENDON
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received04/18/1988
Decision Date 05/06/1988
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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