510(k) K131437

MODIFIED CONCENTRIC MICROCATHETER by Concentric Medical, Inc. — Product Code DQO

K131437 is an FDA 510(k) premarket notification submitted by Concentric Medical, Inc. for the device "MODIFIED CONCENTRIC MICROCATHETER". The FDA issued a decision of Substantially Equivalent on October 11, 2013. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Concentric Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2013
Date Received
May 20, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type