FDA.report

510(k) K971474

Device
MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL
Applicant
MEDTRONIC VASCULAR
510(k) number
K971474
Product code
DTE  
Decision
Substantially Equivalent (SESE)
Decision date
1997-07-14
Date received
1997-04-23
Regulation
870.3600
Classification name
Pulse-generator, Pacemaker, External
Medical specialty
Cardiovascular
Review panel
Cardiovascular
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
LORNA J HARMUTH
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 · openFDA JSON

Legacy Summary

summary

FDA Review

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