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510(k) K214107

XO CROSS CORONARY Support Catheter by Transit Scientific, LLC — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2022
Date Received
December 29, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

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