EasyPath RF Introducer Sheath

Bronchoscope (flexible Or Rigid)

Broncus Medical, Inc

The following data is part of a premarket notification filed by Broncus Medical, Inc with the FDA for Easypath Rf Introducer Sheath.

Pre-market Notification Details

Device IDK200702
510k NumberK200702
Device Name:EasyPath RF Introducer Sheath
ClassificationBronchoscope (flexible Or Rigid)
Applicant Broncus Medical, Inc 125 Nicholson Lane San Jose,  CA  95134
ContactRobin Bush
CorrespondentRobin Bush
Broncus Medical, Inc 125 Nicholson Lane San Jose,  CA  95134
Product CodeEOQ  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-18
Decision Date2021-01-14

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