Cleared Traditional

K141209 - EMBOZENE COLOR-ADVANCED MICROSPHERES

K141209 is an FDA 510(k) clearance for EMBOZENE COLOR-ADVANCED MICROSPHERES, manufactured by Celonova Biosciences, Inc.. The device is a Class 2 Cardiovascular device with product code KRD cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K141209 · Celonova Biosciences, Inc. · Cardiovascular device
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Aug 2014
Decision
90d
Days
Class 2
Risk

K141209 is an FDA 510(k) clearance for the EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHE.... Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Celonova Biosciences, Inc. (San Antonio, US). The FDA issued a Cleared decision on August 7, 2014 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3300 - 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 Celonova Biosciences, Inc. devices

FDA 510(k) Submission Details - K141209

510(k) Number K141209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2014
Decision Date August 07, 2014
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRD Device Classification - Class 2, Special Controls

Product Code KRD Device, Vascular, For Promoting Embolization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3300
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 - KRD Device, Vascular, For Promoting Embolization

All 98
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K141209.
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GEL-BEAD EMBOLIZATION SPHERES
K133237 · Vascular Solutions, Inc. · Apr 2014
AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35
K133626 · MicroVention, Inc. · Dec 2013
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
K133208 · Boston Scientific Corp · Nov 2013