MICROSHEATH LP AND LP-AT

Catheter, Percutaneous

FLOWCARDIA, INC.

The following data is part of a premarket notification filed by Flowcardia, Inc. with the FDA for Microsheath Lp And Lp-at.

Pre-market Notification Details

Device IDK080849
510k NumberK080849
Device Name:MICROSHEATH LP AND LP-AT
ClassificationCatheter, Percutaneous
Applicant FLOWCARDIA, INC. 745 N. PASTORIA AVE. Sunnyvale,  CA  94085
ContactDustin Michaels
CorrespondentDustin Michaels
FLOWCARDIA, INC. 745 N. PASTORIA AVE. Sunnyvale,  CA  94085
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-03-26
Decision Date2008-07-25
Summary:summary

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