Cleared Traditional

K181529 - Vanguard IEP Peripheral Balloon Angiopl...

K181529 is the FDA 510(k) clearance for Vanguard IEP Peripheral Balloon Angiopl... by Contego Medical, LLC. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K181529 · Contego Medical, LLC · Cardiovascular device
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Dec 2018
Decision
178d
Days
Class 2
Risk

K181529 is an FDA 510(k) clearance for the Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Pr.... Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Contego Medical, LLC (Raleigh, US). The FDA issued a Cleared decision on December 6, 2018 after a review of 178 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Contego Medical, LLC devices

Submission Details

510(k) Number K181529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2018
Decision Date December 06, 2018
Days to Decision 178 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
53d slower than avg
Panel avg: 125d · This submission: 178d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

Qrac, LLC
Debra Cogan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT03271710 Completed Interventional Industry-sponsored

Study to Evaluate the Lower Extremity Intervention With Integrated Embolic Protection Using the Vanguard IEP System

A Single-Arm, Multicenter Study for the Lower Extremities Using the Vanguard IEP Peripheral Balloon Angioplasty System With Integrated Embolic Protection

113
Patients (actual)
9
Sites
Treatment
Purpose
Open label
Masking
Condition studied Peripheral Arterial Disease; Intermittent Claudication; Atherosclerosis of Femoral Artery
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Thomas Zeller, Prof.
Sponsor Contego Medical, Inc. (industry)
Started 2017-09-01 → Primary completion 2018-11-30 → Completed 2018-12-30
Primary outcome
Freedom from MAE, defined as death, amputation and target vessel revascularization (TVR)
Secondary outcome
Technical Success
Study completed - no results published. This trial concluded in 2018 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

Regulatory Peers - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 243
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K181529.
Cronus HP PTA Balloon Catheter
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Ultraverse 014 and 018 PTA Balloon Dilatation Catheters
K192318 · Bard Peripheral Vascular, Inc. · Oct 2019
EverCrossTM 0.035 OTW PTA Dilatation Catheter
K190753 · Medtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.) · Apr 2019
Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System)
K181128 · Contego Medical, LLC · Sep 2018
Atlas Gold PTA Dilatation Catheter
K181323 · C.R. Bard, Inc. · Aug 2018
018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
K180007 · Creagh Medical, Ltd. · Apr 2018