510(k) K143412

ADROIT Guiding Catheter by Cordis Corporation — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2015
Date Received
November 28, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type