JOSTRA VENT CATHETERS, MODELS LV & HKV

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 Vent Catheters, Models Lv & Hkv.

Pre-market Notification Details

Device IDK022022
510k NumberK022022
Device Name:JOSTRA VENT CATHETERS, MODELS LV & HKV
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 Received2002-06-20
Decision Date2002-09-11
Summary:summary

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