Cleared Special

K143038 - Gel-Block 10X embolization pledgets

K143038 is the FDA 510(k) clearance for Gel-Block 10X embolization pledgets by Vascular Solutions, Inc.. It is a Class 2 Cardiovascular device (product code KRD) cleared through the Special 510(k) pathway after a 29-day FDA review.

K143038 · Vascular Solutions, Inc. · Cardiovascular device
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Nov 2014
Decision
29d
Days
Class 2
Risk

K143038 is an FDA 510(k) clearance for the Gel-Block 10X embolization pledgets. 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 November 20, 2014 after a review of 29 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 Vascular Solutions, Inc. devices

Submission Details

510(k) Number K143038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2014
Decision Date November 20, 2014
Days to Decision 29 days
Submission Type Special
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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 89
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K143038.
AZUR CX Detachable 35 Coils
K151358 · MicroVention, Inc. · Sep 2015
LifePearl Microshperes
K150958 · MicroVention, Inc. · Sep 2015
Retracta Detachable Embolization Coil
K151676 · Cook Incorporated · Jul 2015
IDC INTERLOCKING DETACHABLE COIL
K141378 · Boston Scientific Corporation · Oct 2014
GEL-BEAD EMBOLIZATION SPHERES
K133237 · Vascular Solutions, Inc. · Apr 2014
AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35
K133626 · MicroVention, Inc. · Dec 2013