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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Peripheral, Atherectomy
510(k) Number K935929
Device Name MICROTRACK
Applicant
Devices For Vascular Intervention, Inc.
595 Penobscot Dr.
Redwood City,  CA  94063
Correspondent
Devices For Vascular Intervention, Inc.
595 Penobscot Dr.
Redwood City,  CA  94063
Regulation Number870.4875
Classification Product Code
MCW  
Date Received12/13/1993
Decision Date 03/10/1994
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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