510(k) K181757

Günther Tulip® Vena Cava Filter Retrieval Set by Cook Incorporated — Product Code MMX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2018
Date Received
July 2, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Percutaneous Retrieval
Device Class
Class II
Regulation Number
870.5150
Review Panel
CV
Submission Type