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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 K911747
Device Name PRO-GUIDE
Applicant
American Interventional Technology
5157 Parkview Ct.
Lilburn,  GA  30247
Applicant Contact JOE E.BROWN
Correspondent
American Interventional Technology
5157 Parkview Ct.
Lilburn,  GA  30247
Correspondent Contact JOE E.BROWN
Regulation Number870.1250
Classification Product Code
DQY  
Date Received04/18/1991
Decision Date 09/18/1991
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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