THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200

Catheter For Crossing Total Occlusions

FLOWCARDIA, INC.

The following data is part of a premarket notification filed by Flowcardia, Inc. with the FDA for The Crosser S6 Catheter, The Crosser System Electronics, Model Crus6, Gen200.

Pre-market Notification Details

Device IDK092175
510k NumberK092175
Device Name:THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-07-21
Decision Date2010-02-17
Summary:summary

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