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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Vascular, For Promoting Embolization
510(k) Number K061790
Device Name PVA PLUS, MAXISTAT PVA, MICROSTAT PVA FOAM EMBOLIZATION PARTICLES
Applicant
Protein Polymer Technologies, Inc.
10655 Sorrento Valley Rd.
San Diego,  CA  92121
Applicant Contact RADINE POBUDA
Correspondent
Protein Polymer Technologies, Inc.
10655 Sorrento Valley Rd.
San Diego,  CA  92121
Correspondent Contact RADINE POBUDA
Regulation Number870.3300
Classification Product Code
KRD  
Subsequent Product Code
HCG  
Date Received06/26/2006
Decision Date 09/19/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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