Cleared Traditional

K133237 - GEL-BEAD EMBOLIZATION SPHERES

K133237 is an FDA 510(k) clearance for GEL-BEAD EMBOLIZATION SPHERES, manufactured by Vascular Solutions, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K133237

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.

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 99
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