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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K911270
Device Name LEOCOR GUIDING CATHETER
Applicant
Leocor, Inc.
1301 Regents Pk. Dr.
Houston,  TX  77058
Applicant Contact ROGER W SNYDER
Correspondent
Leocor, Inc.
1301 Regents Pk. Dr.
Houston,  TX  77058
Correspondent Contact ROGER W SNYDER
Regulation Number870.1200
Classification Product Code
DQO  
Date Received03/22/1991
Decision Date 01/17/1992
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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