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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
510(k) Number K984183
Device Name PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451
Applicant
Possis Medical, Inc.
9055 Evergreen Blvd. NW
Minneapolis,  MN  55433
Applicant Contact TIMOTHY J KAPPERS
Correspondent
Possis Medical, Inc.
9055 Evergreen Blvd. NW
Minneapolis,  MN  55433
Correspondent Contact TIMOTHY J KAPPERS
Regulation Number870.3450
Classification Product Code
DYF  
Date Received11/23/1998
Decision Date 02/01/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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