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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K914422
Device Name DEVICES FOR VASCU INTERVENT ROTAT HEMOSTAT VALVE
Applicant
DEVICES FOR VASCULAR INTERVENTION, INC.
595 PENOBSCOT DR.
REDWOOD CITY,  CA  94063
Applicant Contact KARL HALL
Correspondent
DEVICES FOR VASCULAR INTERVENTION, INC.
595 PENOBSCOT DR.
REDWOOD CITY,  CA  94063
Correspondent Contact KARL HALL
Regulation Number870.1250
Classification Product Code
DQY  
Date Received10/03/1991
Decision Date 12/18/1991
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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