Cleared Traditional

Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System) (K181128) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence.

K181128 · Contego Medical, LLC · Cardiovascular device
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Sep 2018
Decision
129d
Days
Class 2
Risk

K181128 is an FDA 510(k) clearance for the Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protecti.... 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 September 6, 2018 after a review of 129 days - within the typical 510(k) review window.

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 K181128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2018
Decision Date September 06, 2018
Days to Decision 129 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
4d slower than avg
Panel avg: 125d · This submission: 129d
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
NCT02501148 Completed Observational Industry-sponsored

A Multi-Center Study to Evaluate Acute Safety and Clinical Performance of Paladin® Carotid Post-Dilation Balloon System With Integrated Embolic Protection

106
Patients (actual)
5
Sites
Condition studied Carotid Artery Stenoses
Eligibility All sexes · 18 Years+
Principal investigator Prof. Thomas Zeller, MD
Sponsor Contego Medical, Inc. (industry)
Started 2015-08-01 → Primary completion 2016-09-01 → Completed 2016-10-01
Primary outcome
Device-related MAE
Study completed - no results published. This trial concluded in 2016 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 402
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