510(k) K131772

CANTATA(R) 2.9 MICROCATHETER by Cook, Inc. — Product Code KRA

K131772 is an FDA 510(k) premarket notification submitted by Cook, Inc. for the device "CANTATA(R) 2.9 MICROCATHETER". The FDA issued a decision of Substantially Equivalent on February 20, 2014. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210. Cook, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2014
Date Received
June 17, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Continuous Flush
Device Class
Class II
Regulation Number
870.1210
Review Panel
CV
Submission Type