FDA.report

510(k) K973360

Device
MEDTRONIC MODEL 6416 TRANSVENOUS BIPOLAR TEMPORARY PACING LEAD
Applicant
MEDTRONIC VASCULAR
510(k) number
K973360
Product code
LDF  
Decision
Substantially Equivalent (SESE)
Decision date
1998-05-26
Date received
1997-09-08
Regulation
870.3680
Classification name
Electrode, Pacemaker, Temporary
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
SUSAN NODDIN
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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