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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 K904984
Device Name ADVANCE 418(TM)
Applicant
Peripheral Systems Group
1395 Charleston Rd.
Mountain View,  CA  94043
Applicant Contact JESSICA AYRES
Correspondent
Peripheral Systems Group
1395 Charleston Rd.
Mountain View,  CA  94043
Correspondent Contact JESSICA AYRES
Regulation Number870.1250
Classification Product Code
LIT  
Date Received11/02/1990
Decision Date 04/12/1991
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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