Cleared Traditional

K073417 - EMBOZENE MICROSPHERES

K073417 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 Traditional 510(k) pathway after a 377-day FDA review.

K073417 · Celonova Biosciences, Inc. · Cardiovascular device
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Dec 2008
Decision
377d
Days
Class 2
Risk

K073417 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. (Newnan, US). The FDA issued a Cleared decision on December 15, 2008 after a review of 377 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K073417

510(k) Number K073417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2007
Decision Date December 15, 2008
Days to Decision 377 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
252d slower than avg
Panel avg: 125d · This submission: 377d
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 K073417.
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HYDROCOIL EMBOLIC SYSTEMS (HES)
K071939 · MicroVention, Inc. · Jan 2008
FLIPPER DETACHABLE EMBOLIZATION COILS
K063619 · Cook, Inc. · Dec 2006