TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B

Reservoir, Blood, Cardiopulmonary Bypass

MEDTRONIC VASCULAR

The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Trillium Myotherm Xp Cardioplegia Delivery System, Models 41, 41-b.

Pre-market Notification Details

Device IDK011864
510k NumberK011864
Device Name:TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B
ClassificationReservoir, Blood, Cardiopulmonary Bypass
Applicant MEDTRONIC VASCULAR 7611 NORTHLAND DR. Minneapolis,  MN  55428
ContactMarie Holm
CorrespondentMarie Holm
MEDTRONIC VASCULAR 7611 NORTHLAND DR. Minneapolis,  MN  55428
Product CodeDTN  
CFR Regulation Number870.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-06-14
Decision Date2001-07-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20613994947776 K011864 000
20613994947769 K011864 000

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