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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Balloon Inflation
510(k) Number K910205
Device Name LP-60 LOW PRESSURE INFLATION DEVICE
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 Number870.1650
Classification Product Code
MAV  
Date Received01/16/1991
Decision Date 02/25/1991
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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