Cleared Traditional

K093813 - OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE

K093813 is an FDA 510(k) clearance for OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE, manufactured by Imbiotechnologies. The device is a Class 2 Cardiovascular device with product code KRD cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K093813 · Imbiotechnologies · Cardiovascular device
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May 2010
Decision
150d
Days
Class 2
Risk

K093813 is an FDA 510(k) clearance for the OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE. Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Imbiotechnologies (North Attleboro, US). The FDA issued a Cleared decision on May 10, 2010 after a review of 150 days - an extended review cycle.

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 Imbiotechnologies devices

FDA 510(k) Submission Details - K093813

510(k) Number K093813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2009
Decision Date May 10, 2010
Days to Decision 150 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
25d slower than avg
Panel avg: 125d · This submission: 150d
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 100
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