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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K151896
Device Name Houdini Catheter
Applicant
Cruzar Medsystems, Inc.
50 Braintree Hill Office Park Suite 301
Braintree,  MA  02184
Applicant Contact Tom Kramer
Correspondent
Cruzar Medsystems, Inc.
50 Braintree Hill Office Park Suite 301
Braintree,  MA  02184
Correspondent Contact Gina To
Regulation Number870.1250
Classification Product Code
DQY  
Date Received07/10/2015
Decision Date 12/07/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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