MEDTRONIC PERMANENT LEAD INTRODUCER, VARIOUS MDLS

Introducer, Catheter

MEDTRONIC VASCULAR

The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Medtronic Permanent Lead Introducer, Various Mdls.

Pre-market Notification Details

Device IDK911236
510k NumberK911236
Device Name:MEDTRONIC PERMANENT LEAD INTRODUCER, VARIOUS MDLS
ClassificationIntroducer, Catheter
Applicant MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. Minneapolis,  MN  55432
ContactTracy A Malm
CorrespondentTracy A Malm
MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. Minneapolis,  MN  55432
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-03-20
Decision Date1991-06-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10613994397826 K911236 000
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00681490142977 K911236 000
10721902577663 K911236 000
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10721902577632 K911236 000
10721902577625 K911236 000
00721902577536 K911236 000
00721902577482 K911236 000
00681490143172 K911236 000
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10613994391589 K911236 000
10613994391572 K911236 000
10613994391565 K911236 000
10613994391558 K911236 000
10681490143858 K911236 000
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00681490143653 K911236 000
00681490143509 K911236 000
00681490143455 K911236 000
00681490143349 K911236 000
00721902577468 K911236 000

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