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510(k) K211679

Xtractor device by Xcardia Innovation , Ltd. — Product Code DRE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 2022
Date Received
June 1, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Vessel, For Percutaneous Catheterization
Device Class
Class II
Regulation Number
870.1310
Review Panel
CV
Submission Type

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