EXALT Model B Single-Use Bronchoscope

Bronchoscope (flexible Or Rigid)

Boston Scientific Corporation

The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Exalt Model B Single-use Bronchoscope.

Pre-market Notification Details

Device IDK222014
510k NumberK222014
Device Name:EXALT Model B Single-Use Bronchoscope
ClassificationBronchoscope (flexible Or Rigid)
Applicant Boston Scientific Corporation 100 Boston Scientific Way Marlborough,  MA  01752
ContactCarter Navarro
CorrespondentCarter Navarro
Boston Scientific Corporation 100 Boston Scientific Way Marlborough,  MA  01752
Product CodeEOQ  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-08
Decision Date2022-07-28

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