EXALT Model D Single-Use Duodenoscope, EXALT Controller

Duodenoscope And Accessories, Flexible/rigid

Boston Scientific Corporation

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

Pre-market Notification Details

Device IDK193202
510k NumberK193202
Device Name:EXALT Model D Single-Use Duodenoscope, EXALT Controller
ClassificationDuodenoscope And Accessories, Flexible/rigid
Applicant Boston Scientific Corporation 100 Boston Scientific Way Marlborough,  MA  01752
ContactCarter Navarro
Product CodeFDT  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-20
Decision Date2019-12-13
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.