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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Blood-Pressure, Extravascular
510(k) Number K103715
Device Name COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE
Applicant
Mirador Biomedical, Inc.
2815 Wastlake Ave.
Suite 300
Seattle,  WA  98102
Applicant Contact JUSTIN HULVERSHORN
Correspondent
Mirador Biomedical, Inc.
2815 Wastlake Ave.
Suite 300
Seattle,  WA  98102
Correspondent Contact JUSTIN HULVERSHORN
Regulation Number870.2850
Classification Product Code
DRS  
Subsequent Product Code
DXG  
Date Received12/21/2010
Decision Date 01/20/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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