CONDUCER HEAT EXCHANGER

Heat-exchanger, 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 Conducer Heat Exchanger.

Pre-market Notification Details

Device IDK923311
510k NumberK923311
Device Name:CONDUCER HEAT EXCHANGER
ClassificationHeat-exchanger, 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 CodeDTR  
CFR Regulation Number870.4240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-07-07
Decision Date1992-09-18

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