HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20

Analyzer, Heparin, Automated

MEDTRONIC VASCULAR

The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Heparin Dose Response Cartridge, Model 304-20.

Pre-market Notification Details

Device IDK042070
510k NumberK042070
Device Name:HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20
ClassificationAnalyzer, Heparin, Automated
Applicant MEDTRONIC VASCULAR 7611 NORTHLAND DR. Minneapolis,  MN  55428
ContactDawn Stenstrom
CorrespondentDawn Stenstrom
MEDTRONIC VASCULAR 7611 NORTHLAND DR. Minneapolis,  MN  55428
Product CodeJOX  
CFR Regulation Number864.5680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-08-02
Decision Date2004-10-01
Summary:summary

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