JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

JOSTRA AG

The following data is part of a premarket notification filed by Jostra Ag with the FDA for Jostra Retrograde Cardioplegia Cannulae.

Pre-market Notification Details

Device IDK014303
510k NumberK014303
Device Name:JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant JOSTRA AG 478 MEDIA RD. Oxford,  PA  19363
ContactKathleen Johnson
CorrespondentKathleen Johnson
JOSTRA AG 478 MEDIA RD. Oxford,  PA  19363
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-12-31
Decision Date2002-03-26
Summary:summary

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