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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 the device name listed in this FDA 510(k) record. The listed applicant is Venturemed Group, Inc.. It received FDA 510(k) clearance on 2020-09-11 under 510(k) 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. The listed applicant is Venturemed Group, Inc.. The 510(k) number is K202187.

When did FLEX Vessel Prep System receive FDA 510(k) clearance?

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

Who is the listed applicant for FLEX Vessel Prep System?

The FDA 510(k) record lists Venturemed Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Venturemed Group, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K152789FLEX SCORING CATHETER

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Official Source

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

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