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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, continuous flush
510(k) Number K231821
Device Name XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)
Applicant
Transit Scientific, LLC
2757 South 300 West, Suite E
Salt Lake City,  UT  84115
Applicant Contact Jennifer Arnold
Correspondent
University of Utah, Center for Medical Innovation
10 North 1900 East
EHSL Rm. 22
Salt Lake City,  UT  84112
Correspondent Contact Spencer Walker
Regulation Number870.1210
Classification Product Code
KRA  
Date Received06/21/2023
Decision Date 11/29/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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