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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 K232258
Device Name XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter
Applicant
Transit Scientific, LLC
2757 S. 300 W, Suite E
Salt Lake City,  UT  84115
Applicant Contact Lilly Myers
Correspondent
University of Utah, Center For Medical Innovation
10 N. 1900 E.
Ehsl Rm. 22
Salt Lake City,  UT  84112
Correspondent Contact Spencer Walker
Regulation Number870.1250
Classification Product Code
PNO  
Date Received07/31/2023
Decision Date 06/17/2024
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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