SARNS RETROGRADE CANNULA

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

3M HEALTH CARE, SARNS

The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Sarns Retrograde Cannula.

Pre-market Notification Details

Device IDK915193
510k NumberK915193
Device Name:SARNS RETROGRADE CANNULA
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor,  MI  48106
ContactCathy L Simpson
CorrespondentCathy L Simpson
3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor,  MI  48106
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-11-19
Decision Date1992-03-04

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