FDA.report

510(k) K921674

Device
LIFEPORT INFUSION SET AND INFUSION SET W/ Y SITE
Applicant
STRATO MEDICAL CORP.
510(k) number
K921674
Product code
FPA  
Decision
Substantially Equivalent (SESE)
Decision date
1992-09-23
Date received
1992-04-08
Regulation
880.5440
Classification name
Set, Administration, Intravascular
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
NANCY C HALL
Address
123 Brimbal Ave. P.O.B.3148 Beverly MA US 01915 01915

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
H787LPS30255LifeportNAVILYST MEDICAL, INC.2016-09-20
H787LPS30235LifeportNAVILYST MEDICAL, INC.2016-09-20
H787LPS30175LifeportNAVILYST MEDICAL, INC.2016-09-20
H787LPS30095LifeportNAVILYST MEDICAL, INC.2016-09-20
H787LPS30085LifeportNAVILYST MEDICAL, INC.2016-09-20
H787LPS30075LifeportNAVILYST MEDICAL, INC.2016-09-20
H787LPS30065LifeportNAVILYST MEDICAL, INC.2016-09-20
H787LPS30055LifeportNAVILYST MEDICAL, INC.2016-09-20
H787LPS30045LifeportNAVILYST MEDICAL, INC.2016-09-20

Legacy Summary

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FDA Review

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