Cleared Traditional

Plato MICROCATH 27B Microcatheter (K143398) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K143398 · Scientia Vascular, LLC · Cardiovascular device
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Jun 2015
Decision
212d
Days
Class 2
Risk

K143398 is an FDA 510(k) clearance for the Plato MICROCATH 27B Microcatheter. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Scientia Vascular, LLC (Salt Lake City, US). The FDA issued a Cleared decision on June 26, 2015 after a review of 212 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Scientia Vascular, LLC devices

Submission Details

510(k) Number K143398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2014
Decision Date June 26, 2015
Days to Decision 212 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 125d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 156
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