CAPERE Thrombectomy System

Mechanical Thrombolysis Catheter

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 IDK192935
501k NumberK192935
Device Name:CAPERE Thrombectomy System
ClassificationMechanical Thrombolysis Catheter
Applicant Vascular Medcure, Inc. 1500 S. Sunkist St. - Suite H Anaheim,  CA  92806
ContactJeffrey P Dumontelle
CorrespondentJanice M Hogan
Hogan & Lovells US LPP 1735 Market Street, Suite 2300 Philadelphia,  PA  19103
Product CodeQEY  
CFR Regulation Number870.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
501k Review PanelCardiovascular
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-17
Decision Date2019-11-15

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