FLEX Vessel Prep System— 510(k) K202187

Substantially Equivalent

Venturemed Group, Inc.

FDA 510(k) clearance K202187 for FLEX Vessel Prep System, Substantially Equivalent on 2020-09-11. Applicant: Venturemed Group, Inc..

Clearance details

Applicant: Venturemed Group, Inc.
Product code: Code PNO
Advisory panel: Cardiovascular
Date received: 2020-08-04
Decision date: 2020-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PNO

product code PNO

Malfunction: 1,646
Total: 1,646

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.