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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, embolectomy
510(k) Number K113757
Device Name ASPIRE MAX ASPIRATION CATHETER
Original Applicant
CONTROL MEDICAL TECHNOLOGY, LLC
136 heber avenue, suite 101,
po box 681013
park city,  UT  84068
Original Contact shawn p fojtik
Regulation Number870.5150
Classification Product Code
DXE  
Date Received12/21/2011
Decision Date 02/22/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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