510(k) K173651

Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set by Fresenius Medical Care Renal Therapies Group, LLC — Product Code KDJ

K173651 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care Renal Therapies Group, LLC for the device "Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set". The FDA issued a decision of Substantially Equivalent on February 14, 2018. The device falls under product code KDJ (Set, Administration, For Peritoneal Dialysis, Disposable), a Class II device regulated under 21 CFR 876.5630. Fresenius Medical Care Renal Therapies Group, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2018
Date Received
November 28, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, For Peritoneal Dialysis, Disposable
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type