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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 K871021
Device Name GUIDING CATHETERS 9F JL4
Applicant
Devices For Vascular Intervention, Inc.
595 Penobscot Dr.
Redwood City,  CA  94063
Applicant Contact JAMES F PFEIFFER
Correspondent
Devices For Vascular Intervention, Inc.
595 Penobscot Dr.
Redwood City,  CA  94063
Correspondent Contact JAMES F PFEIFFER
Regulation Number870.1200
Classification Product Code
DQO  
Date Received03/16/1987
Decision Date 06/16/1987
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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