SARNS ARTERIAL CANNULAE WITH DURAFLO TREATMENT

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

3M HEALTH CARE

The following data is part of a premarket notification filed by 3m Health Care with the FDA for Sarns Arterial Cannulae With Duraflo Treatment.

Pre-market Notification Details

Device IDK964373
510k NumberK964373
Device Name:SARNS ARTERIAL CANNULAE WITH DURAFLO TREATMENT
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant 3M HEALTH CARE 6200 JACKSON RD. Ann Arbor,  MI  48103 -9300
ContactJason Smith
CorrespondentJason Smith
3M HEALTH CARE 6200 JACKSON RD. Ann Arbor,  MI  48103 -9300
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-11-01
Decision Date1997-06-18
Summary:summary

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