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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Flow Directed
510(k) Number K911840
Device Name INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER
Applicant
Intec Medical, Inc.
C/O Biometric Research Inst
1401 Wilson Blvd., Suite 400
Arlington,  VA  22209
Applicant Contact GLENN A RAHMOELLER
Correspondent
Intec Medical, Inc.
C/O Biometric Research Inst
1401 Wilson Blvd., Suite 400
Arlington,  VA  22209
Correspondent Contact GLENN A RAHMOELLER
Regulation Number870.1240
Classification Product Code
DYG  
Date Received04/25/1991
Decision Date 06/03/1991
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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