MODEL 6984M LEAD EXTENDER KIT

Pacemaker Lead Adaptor

MEDTRONIC VASCULAR

The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Model 6984m Lead Extender Kit.

Pre-market Notification Details

Device IDK915724
510k NumberK915724
Device Name:MODEL 6984M LEAD EXTENDER KIT
ClassificationPacemaker Lead Adaptor
Applicant MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. Minneapolis,  MN  55432
ContactTracy Malm
CorrespondentTracy Malm
MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. Minneapolis,  MN  55432
Product CodeDTD  
CFR Regulation Number870.3620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-12-20
Decision Date1992-02-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00681490153621 K915724 000

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