ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device

Peripheral Mechanical Thrombectomy With Aspiration

Boston Scientific Corporation

The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Zelantedvt Thrombectomy System, Zelantedvt Clothunter Helical Rotation Device.

Pre-market Notification Details

Device IDK202218
510k NumberK202218
Device Name:ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device
ClassificationPeripheral Mechanical Thrombectomy With Aspiration
Applicant Boston Scientific Corporation 3 Scimed Place Maple Grove,  MN  55311
ContactVanessa Fowler
CorrespondentVanessa Fowler
Boston Scientific Corporation 3 Scimed Place Maple Grove,  MN  55311
Product CodeQEW  
CFR Regulation Number870.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-06
Decision Date2020-10-02

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