FDA.report

510(k) K914460

Device
MEDTRONIC MODEL 5407S, 5807S & 5410S SURG CABLES
Applicant
MEDTRONIC VASCULAR
510(k) number
K914460
Product code
DRF  
Decision
Substantially Equivalent (SESE)
Decision date
1991-11-22
Date received
1991-10-07
Regulation
870.1220
Classification name
Catheter, Electrode Recording, Or Probe, Electrode Recording
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
JOHN M OTTO
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

Related GUDID Devices

Primary DIBrandCompanyPublished
00721902035166NAMEDTRONIC, INC.2016-04-03

Legacy Summary

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FDA Review

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