510(k) K141281

CRIT-LINE CLIP (CLIC) BLOOD CHAMBER by Fresenius Medical Care Renal Therapies Group, LLC — Product Code KOC

K141281 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care Renal Therapies Group, LLC for the device "CRIT-LINE CLIP (CLIC) BLOOD CHAMBER". The FDA issued a decision of Substantially Equivalent on August 14, 2014. The device falls under product code KOC (Accessories, Blood Circuit, Hemodialysis), a Class II device regulated under 21 CFR 876.5820. 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
August 14, 2014
Date Received
May 16, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Blood Circuit, Hemodialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type