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FDA 510(k)

FLEX Vessel Prep System

K-Number: K202187 · 2020-09-11

ApplicantVenturemed Group, Inc.
Decision Date2020-09-11
Product CodePNO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FLEX Vessel Prep System is a medical device manufactured by Venturemed Group, Inc.. It received FDA 510(k) clearance on 2020-09-11 under approval number K202187. The device is classified under product code PNO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEX Vessel Prep System?

FLEX Vessel Prep System is a medical device that received FDA 510(k) clearance on 2020-09-11. It is manufactured by Venturemed Group, Inc.. The 510(k) number is K202187.

When was FLEX Vessel Prep System approved by the FDA?

FLEX Vessel Prep System received FDA 510(k) clearance on 2020-09-11, under approval number K202187.

What company makes FLEX Vessel Prep System?

FLEX Vessel Prep System is manufactured by Venturemed Group, Inc..

What is the FDA product code for FLEX Vessel Prep System?

The FDA product code for FLEX Vessel Prep System is PNO.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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