510(k) K122937

SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX) by Cook, Inc. — Product Code DQO

K122937 is an FDA 510(k) premarket notification submitted by Cook, Inc. for the device "SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX)". The FDA issued a decision of Substantially Equivalent on December 14, 2012. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Cook, Inc. has at least 10 other 510(k) clearances on record.