WOLF Thrombectomy System, 6F

Peripheral Mechanical Thrombectomy With Aspiration

DeVoro Medical, Inc.

The following data is part of a premarket notification filed by Devoro Medical, Inc. with the FDA for Wolf Thrombectomy System, 6f.

Pre-market Notification Details

Device IDK210530
510k NumberK210530
Device Name:WOLF Thrombectomy System, 6F
ClassificationPeripheral Mechanical Thrombectomy With Aspiration
Applicant DeVoro Medical, Inc. 46724 Lakeview Blvd Fremont,  CA  94538
ContactMichael Wallace
CorrespondentRoberta Hines
Northwest Clinical Research Group, Inc. 19836 NE 125th Place Woodinville,  WA  98077
Product CodeQEW  
CFR Regulation Number870.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-24
Decision Date2021-08-27

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