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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, Cutting/Scoring
510(k) Number K221986
Device Name XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter
Applicant
Transit Scientific, LLC
2757 South 300 West, Suite E
Salt Lake City,  UT  84115
Applicant Contact Jennifer Arnold
Correspondent
University of Utah
10 North 1900 East, EHSL Rm, 22B
Salt Lake City,  UT  84112
Correspondent Contact Spencer Walker
Regulation Number870.1250
Classification Product Code
PNO  
Date Received07/06/2022
Decision Date 10/18/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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