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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 K193420
Device Name XO Cross Support Catheter
Applicant
Transit Scientific
2757 S. 300 W, Suite E
Salt Lake City,  UT  84115
Applicant Contact Jenifer Arnold
Correspondent
University of Utah
10 N. 1900 E., Ehsl Rm, 22b
Salt Lake City,  UT  84112
Correspondent Contact Spencer Walker
Regulation Number870.1250
Classification Product Code
DQY  
Date Received12/09/2019
Decision Date 05/06/2020
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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