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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 K802481
Device Name 7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH
Applicant
Waters Assoc., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Waters Assoc., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.1240
Classification Product Code
DYG  
Date Received10/07/1980
Decision Date 10/31/1980
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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