MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING

Introducer, Catheter

MEDTRONIC INC.

The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Micra Introducer Sheath With Hydrophilic Coating.

Pre-market Notification Details

Device IDK132030
510k NumberK132030
Device Name:MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING
ClassificationIntroducer, Catheter
Applicant MEDTRONIC INC. 8200 CORAL SEA STREET MS MVS11 Mounds View,  MN  55112
ContactChechamma Varughese
CorrespondentChechamma Varughese
MEDTRONIC INC. 8200 CORAL SEA STREET MS MVS11 Mounds View,  MN  55112
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-07-01
Decision Date2013-09-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169359888 K132030 000

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