FDA.report

510(k) K911236

Device
MEDTRONIC PERMANENT LEAD INTRODUCER, VARIOUS MDLS
Applicant
MEDTRONIC VASCULAR
510(k) number
K911236
Product code
DYB  
Decision
Substantially Equivalent (SESE)
Decision date
1991-06-18
Date received
1991-03-20
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
TRACY A MALM
Address
7000 Central Ave., NE Minneapolis MN US 55432 55432

FDA Registration Numbers

Source Documents

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

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Legacy Summary

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FDA Review

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