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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K140080
Device Name ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB
Applicant
Codman & Shurtleff, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact HANNAH FOLEY
Correspondent
Codman & Shurtleff, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact HANNAH FOLEY
Regulation Number870.1250
Classification Product Code
DQY  
Date Received01/14/2014
Decision Date 04/24/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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