SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING

Introducer, Catheter

MEDTRONIC VASCULAR

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

Pre-market Notification Details

Device IDK123990
510k NumberK123990
Device Name:SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING
ClassificationIntroducer, Catheter
Applicant MEDTRONIC VASCULAR 3576 Unocal Place Santa Rosa,  CA  95403
ContactKelley Lamke
CorrespondentKelley Lamke
MEDTRONIC VASCULAR 3576 Unocal Place Santa Rosa,  CA  95403
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-12-26
Decision Date2013-04-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169150379 K123990 000
00643169150362 K123990 000
00643169150355 K123990 000
00643169150348 K123990 000
00643169150331 K123990 000
00643169150324 K123990 000
00643169150317 K123990 000
00643169150300 K123990 000

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