CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MODELS CB41 AND CB41-B

Heat-exchanger, Cardiopulmonary Bypass

MEDTRONIC VASCULAR

The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Cbmyotherm Xp Cardioplegia Delivery System With Carmeda Bioactive Surface, Models Cb41 And Cb41-b.

Pre-market Notification Details

Device IDK003724
510k NumberK003724
Device Name:CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MODELS CB41 AND CB41-B
ClassificationHeat-exchanger, Cardiopulmonary Bypass
Applicant MEDTRONIC VASCULAR 7600 NORTHLAND DR. Minneapolis,  MN  55428
ContactMarie Holm
CorrespondentMarie Holm
MEDTRONIC VASCULAR 7600 NORTHLAND DR. Minneapolis,  MN  55428
Product CodeDTR  
CFR Regulation Number870.4240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-12-04
Decision Date2000-12-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20613994947790 K003724 000
20613994947783 K003724 000
20643169766932 K003724 000
20643169766918 K003724 000

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