510(k) K121599

CRIT-LINE CLIP (CLIC) by Fresenius Medical Care-North America — Product Code KOC

K121599 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care-North America for the device "CRIT-LINE CLIP (CLIC)". The FDA issued a decision of Substantially Equivalent on November 9, 2012. The device falls under product code KOC (Accessories, Blood Circuit, Hemodialysis), a Class II device regulated under 21 CFR 876.5820.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 2012
Date Received
June 1, 2012
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