MODEL 6416 TEMPORARY PACING LEAD SYSTEM

Electrode, Pacemaker, Temporary

MEDTRONIC VASCULAR

The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Model 6416 Temporary Pacing Lead System.

Pre-market Notification Details

Device IDK042190
510k NumberK042190
Device Name:MODEL 6416 TEMPORARY PACING LEAD SYSTEM
ClassificationElectrode, Pacemaker, Temporary
Applicant MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. MAIL STOP T-202 Minneapolis,  MN  55432 -3576
ContactPaula Cordero
CorrespondentPaula Cordero
MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. MAIL STOP T-202 Minneapolis,  MN  55432 -3576
Product CodeLDF  
CFR Regulation Number870.3680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-08-12
Decision Date2004-09-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169372764 K042190 000
00643169372757 K042190 000
00643169372740 K042190 000
00885074212784 K042190 000
00885074212777 K042190 000
00885074212760 K042190 000
20613994412984 K042190 000
10885074212804 K042190 000
10885074212798 K042190 000

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