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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 K213466
Device Name Houdini Cross Support Catheter
Applicant
Cruzar Medsystems, Inc.
50 Braintree Hill Office Park Suite 301
Braintree,  MA  02184
Applicant Contact Dave Tornatore
Correspondent
Strategic Quality Solutions, LLC
1594 E. Monaco Ave.
Salt Lake City,  UT  84121
Correspondent Contact Adrienne von Foller
Regulation Number870.1250
Classification Product Code
DQY  
Date Received10/28/2021
Decision Date 10/20/2022
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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