510(k) K161731
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