CHARTIS CATHETER MODEL CHR-CA-12.0

Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector)

PULMONX, INC.

The following data is part of a premarket notification filed by Pulmonx, Inc. with the FDA for Chartis Catheter Model Chr-ca-12.0.

Pre-market Notification Details

Device IDK111522
510k NumberK111522
Device Name:CHARTIS CATHETER MODEL CHR-CA-12.0
ClassificationTube, Tracheal/bronchial, Differential Ventilation (w/wo Connector)
Applicant PULMONX, INC. 700 CHESAPEAKE DRIVE Redwood City,  CA  94063
ContactHans Schulz
CorrespondentHans Schulz
PULMONX, INC. 700 CHESAPEAKE DRIVE Redwood City,  CA  94063
Product CodeCBI  
CFR Regulation Number868.5740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-06-02
Decision Date2011-09-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M776CHRCA120 K111522 000

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