SARNS RETROGRADE CANNULA - AUTO INFLATE

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 - Auto Inflate.

Pre-market Notification Details

Device IDK922471
510k NumberK922471
Device Name:SARNS RETROGRADE CANNULA - AUTO INFLATE
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 Received1992-05-26
Decision Date1993-03-12

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