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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 K904959
Device Name PSG HEMOSTATIC CONTROL VALVE
Applicant
Peripheral Systems Group
1395 Charleston Rd.
Mountain View,  CA  94043
Applicant Contact LINDA GUTHRIE
Correspondent
Peripheral Systems Group
1395 Charleston Rd.
Mountain View,  CA  94043
Correspondent Contact LINDA GUTHRIE
Regulation Number870.1200
Classification Product Code
DQO  
Date Received11/05/1990
Decision Date 12/17/1990
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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