510(k) K121634

INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATOR by Baxter Healthcare Corporation — Product Code FPA

K121634 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATOR". The FDA issued a decision of Substantially Equivalent on Jun 29, 2012. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Baxter Healthcare Corporation has 60 other 510(k) clearances on record.