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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Ultrasound, Intravascular
510(k) Number K030524
Device Name CD LEYCOM 7 FR PRESSURE/VOLUME CATHETER (10 MM ELECTRODE SPACING) PRESSURE/VOLUME COMBINATION CATHETER WITH LUMEN
Applicant
Cd Leycom BV
Argonstraat 116
Zoetermeer,  NL 2718 SP
Applicant Contact T. LOPES
Correspondent
Cd Leycom BV
Argonstraat 116
Zoetermeer,  NL 2718 SP
Correspondent Contact T. LOPES
Regulation Number870.1200
Classification Product Code
OBJ  
Date Received02/19/2003
Decision Date 03/03/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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