FLEX Vessel Prep System

Catheter, Percutaneous, Cutting/scoring

VentureMed Group, Inc.

The following data is part of a premarket notification filed by Venturemed Group, Inc. with the FDA for Flex Vessel Prep System.

Pre-market Notification Details

Device IDK202187
510k NumberK202187
Device Name:FLEX Vessel Prep System
ClassificationCatheter, Percutaneous, Cutting/scoring
Applicant VentureMed Group, Inc. 2800 Camput Drive, Suite 50 Plymouth,  MN  55441
ContactJill Schweiger
CorrespondentJill Schweiger
VentureMed Group, Inc. 2800 Camput Drive, Suite 50 Plymouth,  MN  55441
Product CodePNO  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-04
Decision Date2020-09-11

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.