Cleared Traditional

K023914 - COAXIA FLOCONTROL CATHETER

K023914 is an FDA 510(k) clearance for COAXIA FLOCONTROL CATHETER, manufactured by Coaxia, Inc.. The device is a Class 2 Cardiovascular device with product code MJN cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K023914 · Coaxia, Inc. · Cardiovascular device
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Feb 2003
Decision
88d
Days
Class 2
Risk

K023914 is an FDA 510(k) clearance for the COAXIA FLOCONTROL CATHETER. Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by Coaxia, Inc. (Maple Grove, US). The FDA issued a Cleared decision on February 21, 2003 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Coaxia, Inc. devices

FDA 510(k) Submission Details - K023914

510(k) Number K023914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2002
Decision Date February 21, 2003
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 125d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MJN Device Classification - Class 2, Special Controls

Product Code MJN Catheter, Intravascular Occluding, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 - MJN Catheter, Intravascular Occluding, Temporary

All 64
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K023914.
NUMED PTS X SIZING BALLOON CATHETER
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K033159 · LeMaitre Vascular, Inc. · Dec 2003
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K011535 · Micro Therapeutics, Inc. · Aug 2001
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K011656 · Micro Therapeutics, Inc. · Jun 2001