510(k) K161731

Cleveland Multiport Ventricular Catheter Set by Parker Hannifin Corp. — Product Code HCA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2017
Date Received
June 23, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Ventricular
Device Class
Class II
Regulation Number
882.4100
Review Panel
NE
Submission Type