Aeris Balloon Dialation Catheter

Bronchoscope (flexible Or Rigid)

Bryan Medical , Inc.

The following data is part of a premarket notification filed by Bryan Medical , Inc. with the FDA for Aeris Balloon Dialation Catheter.

Pre-market Notification Details

Device IDK150951
510k NumberK150951
Device Name:Aeris Balloon Dialation Catheter
ClassificationBronchoscope (flexible Or Rigid)
Applicant Bryan Medical , Inc. 3906 Oak St. Cincinnati,  OH  45227
ContactAndy Black
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeEOQ  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2015-04-09
Decision Date2015-06-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
KG1840 K150951 000
KG1640 K150951 000
KG1240 K150951 000
KG1030 K150951 000
KG0930 K150951 000
KG0830 K150951 000
KG0730 K150951 000
KG0630 K150951 000
KG0530 K150951 000

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