TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM

Balloon Aortic Valvuloplasty

BARD PERIPHERAL VASCULAR, INC.

The following data is part of a premarket notification filed by Bard Peripheral Vascular, Inc. with the FDA for True Dilatation Balloon Valvuloplasty Catheter, 20mm X 4.5 Cm, 22mm X 4.5cm, 24 Mm X 4.5cm, 26mm X 4.5cm.

Pre-market Notification Details

Device IDK133569
510k NumberK133569
Device Name:TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM
ClassificationBalloon Aortic Valvuloplasty
Applicant BARD PERIPHERAL VASCULAR, INC. 1307 SOUTH MARY AVENUE SUITE 280 Sunnyvale,  CA  94087
ContactTiffini Diage
CorrespondentTiffini Diage
BARD PERIPHERAL VASCULAR, INC. 1307 SOUTH MARY AVENUE SUITE 280 Sunnyvale,  CA  94087
Product CodeOZT  
CFR Regulation Number870.1255 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-11-20
Decision Date2013-12-20
Summary:summary

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