Capere Thrombectomy System

Peripheral Mechanical Thrombectomy With Aspiration

Vascular Medcure, Inc.

The following data is part of a premarket notification filed by Vascular Medcure, Inc. with the FDA for Capere Thrombectomy System.

Pre-market Notification Details

Device IDK200314
510k NumberK200314
Device Name:Capere Thrombectomy System
ClassificationPeripheral Mechanical Thrombectomy With Aspiration
Applicant Vascular Medcure, Inc. 1500 S. Sunkist St. - Suite H Anaheim,  CA  92806
ContactJeffrey P Dumontelle
CorrespondentJanice M Hogan
Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia,  PA  19103
Product CodeQEW  
CFR Regulation Number870.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelCardiovascular
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-06
Decision Date2020-03-04

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