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510(k) K240257

Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit by Bd — Product Code DTK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 29, 2024
Date Received
January 31, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Intravascular, Cardiovascular
Device Class
Class II
Regulation Number
870.3375
Review Panel
CV
Submission Type

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