IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR

Pump, Blood, Cardiopulmonary Bypass, Non-roller Type

DIDECO S.P.A.

The following data is part of a premarket notification filed by Dideco S.p.a. with the FDA for Ideal Mimesys System With Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket, Adult Membrane Oxygenator.

Pre-market Notification Details

Device IDK032040
510k NumberK032040
Device Name:IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR
ClassificationPump, Blood, Cardiopulmonary Bypass, Non-roller Type
Applicant DIDECO S.P.A. 195 WEST ST. Waltham,  MA  02451 -1163
ContactBarry Sall
CorrespondentBarry Sall
DIDECO S.P.A. 195 WEST ST. Waltham,  MA  02451 -1163
Product CodeKFM  
CFR Regulation Number870.4360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-07-01
Decision Date2003-07-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
38033178241220 K032040 000

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