MODEL 5857-3M LEAD END CAP KIT

Pacemaker Lead Adaptor

MEDTRONIC VASCULAR

The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Model 5857-3m Lead End Cap Kit.

Pre-market Notification Details

Device IDK911048
510k NumberK911048
Device Name:MODEL 5857-3M LEAD END CAP KIT
ClassificationPacemaker Lead Adaptor
Applicant MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. Minneapolis,  MN  55432
ContactJennifer M Marrone
CorrespondentJennifer M Marrone
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 Received1991-03-08
Decision Date1991-04-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994500298 K911048 000
00763000059460 K911048 000

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