MODIFICATION TO THE CROSSER SYSTEM

Catheter For Crossing Total Occlusions

FLOWCARDIA, INC.

The following data is part of a premarket notification filed by Flowcardia, Inc. with the FDA for Modification To The Crosser System.

Pre-market Notification Details

Device IDK091119
510k NumberK091119
Device Name:MODIFICATION TO THE CROSSER SYSTEM
ClassificationCatheter For Crossing Total Occlusions
Applicant FLOWCARDIA, INC. 745 N. PASTORIA AVE. Sunnyvale,  CA  94085
ContactDustin Michaels
CorrespondentDustin Michaels
FLOWCARDIA, INC. 745 N. PASTORIA AVE. Sunnyvale,  CA  94085
Product CodePDU  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-04-17
Decision Date2009-05-15
Summary:summary

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