Cleared Special

K132675 - EMBOZENE MICROSPHERES

K132675 is an FDA 510(k) clearance for EMBOZENE MICROSPHERES, manufactured by Celonova Biosciences, Inc.. The device is a Class 2 Cardiovascular device with product code KRD cleared through the Special 510(k) pathway after a 36-day FDA review.

K132675 · Celonova Biosciences, Inc. · Cardiovascular device
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Oct 2013
Decision
36d
Days
Class 2
Risk

K132675 is an FDA 510(k) clearance for the EMBOZENE MICROSPHERES. 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 October 3, 2013 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3300 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Celonova Biosciences, Inc. devices

FDA 510(k) Submission Details - K132675

510(k) Number K132675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2013
Decision Date October 03, 2013
Days to Decision 36 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 125d · This submission: 36d
Pathway characteristics
Modification to existing cleared device.

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
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