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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 K904491
Device Name TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000
Applicant
Lifestream Int'L, Inc.
2828 N.Crescent River Dr.
The Woodlands,  TX  77381
Applicant Contact THOMAS WERTZ
Correspondent
Lifestream Int'L, Inc.
2828 N.Crescent River Dr.
The Woodlands,  TX  77381
Correspondent Contact THOMAS WERTZ
Regulation Number870.1200
Classification Product Code
DQO  
Date Received10/02/1990
Decision Date 02/01/1991
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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