Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares

Snare, Flexible

Boston Scientific Corporation

The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Captivator Single-use Polypectomy Snares, Captiflex Single-use Polypectomy Snares.

Pre-market Notification Details

Device IDK202478
510k NumberK202478
Device Name:Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares
ClassificationSnare, Flexible
Applicant Boston Scientific Corporation 100 Boston Scientific Way Marlborough,  MA  01752
ContactStephanie Gorman
CorrespondentStephanie Gorman
Boston Scientific Corporation 100 Boston Scientific Way Marlborough,  MA  01752
Product CodeFDI  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-28
Decision Date2020-10-08

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