MEDTRONIC MODEL 5407S, 5807S & 5410S SURG CABLES

Catheter, Electrode Recording, Or Probe, Electrode Recording

MEDTRONIC VASCULAR

The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Medtronic Model 5407s, 5807s & 5410s Surg Cables.

Pre-market Notification Details

Device IDK914460
510k NumberK914460
Device Name:MEDTRONIC MODEL 5407S, 5807S & 5410S SURG CABLES
ClassificationCatheter, Electrode Recording, Or Probe, Electrode Recording
Applicant MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. Minneapolis,  MN  55432
ContactJohn M Otto
CorrespondentJohn M Otto
MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. Minneapolis,  MN  55432
Product CodeDRF  
CFR Regulation Number870.1220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-10-07
Decision Date1991-11-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00721902035166 K914460 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.