SARNS VISIFLOW AORTIC ARCH 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 Visiflow Aortic Arch Cannula.

Pre-market Notification Details

Device IDK874896
510k NumberK874896
Device Name:SARNS VISIFLOW AORTIC ARCH CANNULA
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor,  MI  48106
ContactJoseph W O'donnell
CorrespondentJoseph W O'donnell
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 Received1987-12-01
Decision Date1988-02-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.