Cleared Traditional

K133237 - GEL-BEAD EMBOLIZATION SPHERES

K133237 is the FDA 510(k) clearance for GEL-BEAD EMBOLIZATION SPHERES by Vascular Solutions, Inc.. It is a Class 2 Cardiovascular device (product code KRD) cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K133237 · Vascular Solutions, Inc. · Cardiovascular device
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Apr 2014
Decision
186d
Days
Class 2
Risk

K133237 is an FDA 510(k) clearance for the GEL-BEAD EMBOLIZATION SPHERES. Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Vascular Solutions, Inc. (Minneapolis, US). The FDA issued a Cleared decision on April 25, 2014 after a review of 186 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 Vascular Solutions, Inc. devices

Submission Details

510(k) Number K133237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2013
Decision Date April 25, 2014
Days to Decision 186 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 125d · This submission: 186d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 92
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K133237.
Retracta Detachable Embolization Coil
K151676 · Cook Incorporated · Jul 2015
Gel-Block 10X embolization pledgets
K143038 · Vascular Solutions, Inc. · Nov 2014
IDC INTERLOCKING DETACHABLE COIL
K141378 · Boston Scientific Corporation · Oct 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
AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35
K132083 · MicroVention, Inc. · Oct 2013