HEPARINASE HR ACT CONTROL, MODEL 550-12

Plasma, Coagulation Control

MEDTRONIC VASCULAR

The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Heparinase Hr Act Control, Model 550-12.

Pre-market Notification Details

Device IDK042175
510k NumberK042175
Device Name:HEPARINASE HR ACT CONTROL, MODEL 550-12
ClassificationPlasma, Coagulation Control
Applicant MEDTRONIC VASCULAR 7611 NORTHLAND DR. Minneapolis,  MN  55428
ContactDawn Stenstrom
CorrespondentDawn Stenstrom
MEDTRONIC VASCULAR 7611 NORTHLAND DR. Minneapolis,  MN  55428
Product CodeGGN  
CFR Regulation Number864.5425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-08-11
Decision Date2004-10-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20613994923343 K042175 000

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