Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle

Biopsy Needle

BOSTON SCIENTIFIC CORPORATION

The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle.

Pre-market Notification Details

Device IDK151895
510k NumberK151895
Device Name:Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
ClassificationBiopsy Needle
Applicant BOSTON SCIENTIFIC CORPORATION 100 BOSTON SCIENTIFIC WAY Marlborough,  MA  01752
ContactYingying Gao
CorrespondentYingying Gao
BOSTON SCIENTIFIC CORPORATION 100 BOSTON SCIENTIFIC WAY Marlborough,  MA  01752
Product CodeFCG  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-10
Decision Date2015-10-22
Summary:summary

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