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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Straight
510(k) Number K061766
Device Name EXPRESSWAY INTERMITTENT CATHETER
Applicant
Percutaneous Systems, Incorporated
1300 Crittenden Ln.
Suite 101
Mountain View,  CA  94043
Applicant Contact THOMAS LAWSON
Correspondent
Percutaneous Systems, Incorporated
1300 Crittenden Ln.
Suite 101
Mountain View,  CA  94043
Correspondent Contact THOMAS LAWSON
Regulation Number876.5130
Classification Product Code
EZD  
Date Received06/22/2006
Decision Date 03/09/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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