510(k) K111619

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

K111619 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 July 6, 2011. 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
July 6, 2011
Date Received
June 10, 2011
Clearance Type
Special
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