EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM

Suture, Nonabsorbable, Synthetic, Polypropylene

EDWARDS LIFESCIENCES LLC.

The following data is part of a premarket notification filed by Edwards Lifesciences Llc. with the FDA for Edwards Lifesciences Thruport Knotting System.

Pre-market Notification Details

Device IDK141206
510k NumberK141206
Device Name:EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM
ClassificationSuture, Nonabsorbable, Synthetic, Polypropylene
Applicant EDWARDS LIFESCIENCES LLC. 12050 Lone Peak Pkwy Draper,  UT  84020
ContactNina Brooke
CorrespondentNina Brooke
EDWARDS LIFESCIENCES LLC. 12050 Lone Peak Pkwy Draper,  UT  84020
Product CodeGAW  
CFR Regulation Number878.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-05-09
Decision Date2015-01-16
Summary:summary

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