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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K881088
Device Name ADDITION OF A TIP GUARD TO THE ATHEROCATH(TM)
Applicant
Devices For Vascular Intervention, Inc.
595 Penobscot Dr.
Redwood City,  CA  94063
Applicant Contact DIANE RUPPERT
Correspondent
Devices For Vascular Intervention, Inc.
595 Penobscot Dr.
Redwood City,  CA  94063
Correspondent Contact DIANE RUPPERT
Regulation Number870.1250
Classification Product Code
LIT  
Date Received03/15/1988
Decision Date 05/31/1988
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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