Cleared Abbreviated

K112124 - MICROCATHETER (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K112124 · Navilyst Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
25d
Days
Class 2
Risk

K112124 is an FDA 510(k) clearance for the MICROCATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Navilyst Medical, Inc. (Marlborough, US). The FDA issued a Cleared decision on August 19, 2011 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Navilyst Medical, Inc. devices

Submission Details

510(k) Number K112124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2011
Decision Date August 19, 2011
Days to Decision 25 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 125d · This submission: 25d
Pathway characteristics
Standards-based clearance path.

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 498
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K112124.
Arterial Pressure Monitoring Set/Tray
K254278 · Spectrum Vascular · Mar 2026
DualView Catheter
K250751 · Terumo Corporation · Jul 2025
Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter
K242966 · Gentuity, LLC · Jan 2025
pNOVUS 21 Microcatheter
K242420 · Phenox, Ltd. · Nov 2024
Impress Angiographic Catheter
K233268 · Merit Medical Systems, Inc. · May 2024
Zoom 6F Insert Catheters
K233975 · Imperative Care, Inc. · Apr 2024