510(k) K210838

PROWLER SELECT PLUS; PROWLER EX by Medos International SARL — Product Code KRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2021
Date Received
March 22, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Continuous Flush
Device Class
Class II
Regulation Number
870.1210
Review Panel
CV
Submission Type