Cleared Traditional

K090970 - FLOCONTROL , MODEL 1028

K090970 is an FDA 510(k) clearance for FLOCONTROL, 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 67-day FDA review.

K090970 · Coaxia, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
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Jun 2009
Decision
67d
Days
Class 2
Risk

K090970 is an FDA 510(k) clearance for the FLOCONTROL , MODEL 1028. 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 June 12, 2009 after a review of 67 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 - K090970

510(k) Number K090970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2009
Decision Date June 12, 2009
Days to Decision 67 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
58d faster than avg
Panel avg: 125d · This submission: 67d
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
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