Cleared Traditional

K143398 - Plato MICROCATH 27B Microcatheter

K143398 is an FDA 510(k) clearance for Plato MICROCATH 27B Microcatheter, manufactured by Scientia Vascular, LLC. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K143398 · Scientia Vascular, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K143398

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.

DQO Device Classification - Class 2, Special Controls

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 320
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K143398.
DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak
K161287 · Medtronic Vascular · Aug 2016
Impulse Angiographic Catheter, Expo Angiographic Catheter
K152605 · Boston Scientific Corporation · Oct 2015
AngioDynamics Mariner Angiographic Catheters
K151724 · AngioDynamics, Inc. · Oct 2015
BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER
K133130 · Cook, Inc. · Jan 2015
MODIFIED CONCENTRIC MICROCATHETER
K131437 · Concentric Medical, Inc. · Oct 2013
SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX)
K122937 · Cook, Inc. · Dec 2012