EDWARDS PERCUTANEOUS SHEATH INTRODUCER

Introducer, Catheter

EDWARDS LIFESCIENCES, LLC.

The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Edwards Percutaneous Sheath Introducer.

Pre-market Notification Details

Device IDK121185
510k NumberK121185
Device Name:EDWARDS PERCUTANEOUS SHEATH INTRODUCER
ClassificationIntroducer, Catheter
Applicant EDWARDS LIFESCIENCES, LLC. 12050 LONE PEAK PKWY. Draper,  UT  84020
ContactSpencer Walker
CorrespondentSpencer Walker
EDWARDS LIFESCIENCES, LLC. 12050 LONE PEAK PKWY. Draper,  UT  84020
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-04-18
Decision Date2012-08-22
Summary:summary

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