Cleared Traditional

K202187 - FLEX Vessel Prep System

K202187 is the FDA 510(k) clearance for FLEX Vessel Prep System by Venturemed Group, Inc.. It is a Class 2 Cardiovascular device (product code PNO) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K202187 · Venturemed Group, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2020
Decision
38d
Days
Class 2
Risk

K202187 is an FDA 510(k) clearance for the FLEX Vessel Prep System. Classified as Catheter, Percutaneous, Cutting/scoring (product code PNO), Class II - Special Controls.

Submitted by Venturemed Group, Inc. (Plymouth, US). The FDA issued a Cleared decision on September 11, 2020 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Venturemed Group, Inc. devices

Submission Details

510(k) Number K202187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2020
Decision Date September 11, 2020
Days to Decision 38 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 125d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PNO Catheter, Percutaneous, Cutting/scoring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition To Reduce Vascular Stenosis By Dilatation And Apposition Of The Cutting/scoring Surfaces To The Stenotic Material
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - PNO Catheter, Percutaneous, Cutting/scoring

All 19
Devices cleared under the same product code (PNO) and FDA review panel - the closest regulatory comparables to K202187.
Serranator PTA Serration Balloon Catheter
K220704 · Cagent Vascular, LLC · May 2022
Serranator PTA Serration Balloon Catheter
K213728 · Cagent Vascular, LLC · Dec 2021
Serranator PTA Serration Balloon Catheter
K203437 · Cagent Vascular, LLC · Dec 2020
XO Score Percutaneous Transluminal Angioplasty Scoring Catheter
K193495 · Transit Scientific · May 2020
Serranator PTA Serration Balloon Catheter
K193181 · Cagent Vascular, LLC · Apr 2020
Scoreflex PTA Scoring Balloon Catheter
K182713 · Orbusneich Medical Trading, Inc. · Jun 2019