510(k) K222254

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2023
Date Received
July 27, 2022
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