FDA.report

510(k) K854559

Device
MEDTRONIC PERMANENT LEAD INTRODUCER
Applicant
MEDTRONIC VASCULAR
510(k) number
K854559
Product code
DYB  
Decision
Substantially Equivalent (SESE)
Decision date
1985-12-24
Date received
1985-11-14
Regulation
870.1340
Classification name
Introducer, Catheter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
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
ALAN MARQUARDT
Address
800 53rd Ave., NE P.O. Box 1250 Minneapolis MN US 55440 55440

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Legacy Summary

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FDA Review

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