FDA.report

510(k) K911355

Device
LIFEPORT VASCU ACCESS SYST/PORT INTRO KIT 7015
Applicant
STRATO MEDICAL CORP.
510(k) number
K911355
Product code
LJT  
Decision
Substantially Equivalent (SESE)
Decision date
1991-04-15
Date received
1991-02-21
Regulation
880.5965
Classification name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
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 not indicated by FDA · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
H787LPS70150Lifeport NAVILYST MEDICAL, INC.2015-09-17

Legacy Summary

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FDA Review

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