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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 K913783
Device Name CORDIS PTCA GUIDING CATHETER, MODIFICATION
Applicant
Dow Corning Wright
P.O. Box 100
Arlington,  TN  38002
Applicant Contact ERIN MCGURK-BURLESON
Correspondent
Dow Corning Wright
P.O. Box 100
Arlington,  TN  38002
Correspondent Contact ERIN MCGURK-BURLESON
Regulation Number870.1250
Classification Product Code
DQY  
Date Received08/14/1991
Decision Date 10/18/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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