T-ANASTAFLO

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

EDWARDS LIFESCIENCES RESEARCH MEDICAL

The following data is part of a premarket notification filed by Edwards Lifesciences Research Medical with the FDA for T-anastaflo.

Pre-market Notification Details

Device IDK990396
510k NumberK990396
Device Name:T-ANASTAFLO
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant EDWARDS LIFESCIENCES RESEARCH MEDICAL 6864 SOUTH 300 WEST Midvale,  UT  84047
ContactJohn W Smith
CorrespondentJohn W Smith
EDWARDS LIFESCIENCES RESEARCH MEDICAL 6864 SOUTH 300 WEST Midvale,  UT  84047
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-02-09
Decision Date1999-10-01
Summary:summary

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