Cleared Abbreviated

K112124 - MICROCATHETER

K112124 is the FDA 510(k) clearance for MICROCATHETER by Navilyst Medical, Inc.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Abbreviated 510(k) pathway after a 25-day FDA review.

K112124 · Navilyst Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
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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
Combination Product No
PCCP Authorized No
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 290
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K112124.
IMAGER II ANGIOGRAPHIC CATHETERS
K120893 · Boston Scientific Corp · Mar 2012
MODIFIED CONCENTIRC MICROCATHETER
K113260 · Concentric Medical, Inc. · Mar 2012
NMI 2.8 MICROCATHETER
K113638 · Navilyst Medical, Inc. · Jan 2012
MODIFIED CONCENTRIC MICROCATHETER
K111619 · Concentric Medical, Inc. · Jul 2011
MERIT MARQUIS FLOW SWITCH
K110643 · Merit Medical Systems, Inc. · Jul 2011
EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER
K110103 · Edwards Lifesciences, LLC · Feb 2011