CONDUCER CARDIOPLEGIA SET SITH MP4

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

3M HEALTH CARE, LTD.

The following data is part of a premarket notification filed by 3m Health Care, Ltd. with the FDA for Conducer Cardioplegia Set Sith Mp4.

Pre-market Notification Details

Device IDK922992
510k NumberK922992
Device Name:CONDUCER CARDIOPLEGIA SET SITH MP4
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant 3M HEALTH CARE, LTD. 6200 JACKSON RD. P.O. BOX 1247 Ann Arbor,  MI  48106
ContactCathy L Simpson
CorrespondentCathy L Simpson
3M HEALTH CARE, LTD. 6200 JACKSON RD. P.O. BOX 1247 Ann Arbor,  MI  48106
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-06-22
Decision Date1992-09-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50699753005476 K922992 000

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