MegaVac Mechanical Thrombectomy System

Catheter, Embolectomy

Capture Vascular, Inc.

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

Pre-market Notification Details

Device IDK171493
510k NumberK171493
Device Name:MegaVac Mechanical Thrombectomy System
ClassificationCatheter, Embolectomy
Applicant Capture Vascular, Inc. 620 Mountain Village Blvd. Suite 2c Mountain Village,  CO  81435
ContactAaron Call
CorrespondentAaron Call
Capture Vascular, Inc. 620 Mountain Village Blvd. Suite 2c Mountain Village,  CO  81435
Product CodeDXE  
CFR Regulation Number870.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-05-22
Decision Date2017-08-10
Summary:summary

Trademark Results [MegaVac Mechanical Thrombectomy System]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MEGAVAC MECHANICAL THROMBECTOMY SYSTEM
MEGAVAC MECHANICAL THROMBECTOMY SYSTEM
87685679 not registered Dead/Abandoned
Capture Vascular Inc.
2017-11-15

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