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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 6mm And Greater Diameter
510(k) Number K854845
Device Name INTERVASCULAROCHSNER 50 AND OCHSNER 500 VASCULAR
Applicant
Intervascular, Inc.
4906-A Creekside Dr.
Clearwater,  FL  33520
Applicant Contact GEORGE GOICOECHEA
Correspondent
Intervascular, Inc.
4906-A Creekside Dr.
Clearwater,  FL  33520
Correspondent Contact GEORGE GOICOECHEA
Regulation Number870.3450
Classification Product Code
DSY  
Date Received12/04/1985
Decision Date 08/18/1986
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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