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
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
| 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
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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510(k) Summary PDF or remain unpublished.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