OCHSNER 50 VASCULAR PROSTHESIS

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

INTERVASCULAR, INC.

The following data is part of a premarket notification filed by Intervascular, Inc. with the FDA for Ochsner 50 Vascular Prosthesis.

Pre-market Notification Details

Device IDK905270
510k NumberK905270
Device Name:OCHSNER 50 VASCULAR PROSTHESIS
ClassificationProsthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant INTERVASCULAR, INC. 16331 BAY VISTA DR. Clearwater,  FL  33760 -3130
ContactMichael P Dayton
CorrespondentMichael P Dayton
INTERVASCULAR, INC. 16331 BAY VISTA DR. Clearwater,  FL  33760 -3130
Product CodeDSY  
CFR Regulation Number870.3450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-11-23
Decision Date1991-02-15

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