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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Vessel, For Percutaneous Catheterization
510(k) Number K902469
Device Name BYRD DILATOR SHEATH SET - TEFLON
Applicant
Medical Engineering and Development Institute
P.O.Box 2402
West Lafayette,  IN  47906
Applicant Contact FEARNOT, PHD
Correspondent
Medical Engineering and Development Institute
P.O.Box 2402
West Lafayette,  IN  47906
Correspondent Contact FEARNOT, PHD
Regulation Number870.1310
Classification Product Code
DRE  
Date Received06/04/1990
Decision Date 08/23/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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