510(k) K161731

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

K161731 is an FDA 510(k) premarket notification submitted by Parker Hannifin Corp. for the device "Cleveland Multiport Ventricular Catheter Set". The FDA issued a decision of Substantially Equivalent on March 27, 2017. The device falls under product code HCA (Catheter, Ventricular), a Class II device regulated under 21 CFR 882.4100. Parker Hannifin Corp. has at least 8 other 510(k) clearances on record.

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