510(k) K221470

Langston dual lumen catheter by Vascular Solutions, LLC — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2022
Date Received
May 20, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type