510(k) K232190

6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter by Medtronic Vascular — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2023
Date Received
July 24, 2023
Clearance Type
Special
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