MEDTRONIC INPUT PS INTRODUCER

Introducer, Catheter

MEDTRONIC, INC.

The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Medtronic Input Ps Introducer.

Pre-market Notification Details

Device IDK132617
510k NumberK132617
Device Name:MEDTRONIC INPUT PS INTRODUCER
ClassificationIntroducer, Catheter
Applicant MEDTRONIC, INC. 37A CHERRY HILL DRIVE Danvers,  MA  01923
ContactNisarg Shah
CorrespondentNisarg Shah
MEDTRONIC, INC. 37A CHERRY HILL DRIVE Danvers,  MA  01923
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-21
Decision Date2014-04-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20643169116003 K132617 000
00643169014206 K132617 000
20643169014194 K132617 000
20643169014187 K132617 000
20643169014170 K132617 000
20643169014163 K132617 000
20643169014156 K132617 000
20643169014149 K132617 000
20643169014132 K132617 000
20643169014125 K132617 000
20643169014101 K132617 000
20643169014064 K132617 000
20643169014040 K132617 000
20643169014026 K132617 000
20643169014002 K132617 000
20643169013982 K132617 000
20643169013968 K132617 000
20643169014217 K132617 000
20643169014224 K132617 000
20643169115990 K132617 000
20643169115969 K132617 000
20643169115952 K132617 000
20643169014651 K132617 000
20643169014644 K132617 000
20643169014583 K132617 000
20643169014576 K132617 000
20643169014514 K132617 000
20643169014507 K132617 000
20643169014330 K132617 000
20643169014293 K132617 000
20643169014279 K132617 000
20643169014262 K132617 000
20643169014255 K132617 000
20643169014248 K132617 000
20643169014231 K132617 000
00643169620667 K132617 000

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