LARIAT Sulture Delivery Device

Suture, Nonabsorbable, Synthetic, Polyethylene

SENTREHEART INC.

The following data is part of a premarket notification filed by Sentreheart Inc. with the FDA for Lariat Sulture Delivery Device.

Pre-market Notification Details

Device IDK142241
510k NumberK142241
Device Name:LARIAT Sulture Delivery Device
ClassificationSuture, Nonabsorbable, Synthetic, Polyethylene
Applicant SENTREHEART INC. 300 SAGINAW DR Redwood City,  CA  94063 -0000
ContactKit Cariquitan
CorrespondentKit Cariquitan
SENTREHEART INC. 300 SAGINAW DR Redwood City,  CA  94063 -0000
Product CodeGAT  
CFR Regulation Number878.5000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-13
Decision Date2014-09-12
Summary:summary

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